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Customised penetration tests for municipal utilities with critical infrastructure

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Customised penetration tests for critical infrastructure Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

For companies managing critical infrastructure, we offer a customised, network-based penetration test based on an assumed breach scenario. 

Purpose/Benefit:

An assumed breach scenario assumes that an attacker already has access to a device on your network, enabling a cost-effective and in-depth analysis of how well your defences resist further intrusion and lateral movement within your network. This analysis provides a key basis for effective remediation and a credible assessment of risk. With the growing realisation that strong digital border protection is not enough, this approach has also become increasingly common. It is responsible and realistic to assume that at some point an attacker will get past border protection, or that the organisation will be hit by an insider.

Target audience

Organisations that manage critical infrastructure, such as energy supply, water treatment, transport, and healthcare, face unique cybersecurity challenges. For these organisations, the consequences of a security incident are not only financial, but can also pose serious risks to societal functions and human lives. Working with RISE, an independent and state-owned provider with extensive experience and accreditation, ensures the highest possible objectivity, quality and safety in implementation - which is crucial for our societal functions. 

Method (what/which methods are used to perform the service):

Adopting an 'assumed breach' scenario is an effective and valuable approach in cybersecurity because it assumes that an attacker is already inside the network. This differs from traditional internal vulnerability scanning, which primarily focuses on identifying and correcting potential vulnerabilities before an attacker can exploit them. "The 'assumed breach' approach prepares organisations for the reality of today's cyber threat landscape where advanced attackers often manage to bypass perimeter defences. This approach highlights the importance of detection and response capabilities, defence-in-depth within the network, and previously unknown vulnerabilities, all of which contribute to a more resilient security posture.

By simulating attacks that have already overcome initial defences, organisations can assess how well their internal controls work to identify and stop attackers from spreading and gaining access to sensitive resources. It also enables testing of how effectively the incident response team can identify and respond to incidents in real time, as well as how well security systems can detect and counter advanced threats.

Our tests are planned and carried out in close dialogue with the client, to ensure the greatest possible value and relevance of the result. Content, scope and boundaries are carefully defined and we always recommend the methodology that we believe best meets the needs and conditions of the organisation.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Test results in the form of a report including identified vulnerabilities, their severity and recommendations for remediation. 

Delivery time:

Regular meetings, final report and recommendations for action. 

Area: Cyber security
Critical infrastructure
Field measurements: No Price type: 1 Division: Division Digital Systems and Societal Transformation Preparation: No preparation required Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation

Are the tests on-site or remote?

Primarily remote, but depending on the circumstances we can also carry out work on-site.

Instrument: Not applicable

How is this different from automated vulnerability scanning?

We see this as complementary and focus mainly on the things that automated tools do not find. This could be testing very specialised software or detecting vulnerabilities that require a bit more deep dive and manual testing.

How are the results delivered?

Primarily through a final report presenting the results together with proposals for action or changes, but also through regular meetings and contacts to discuss the findings as the work progresses.

General area: Not applicable Divison (OLD): Division Digital Systems and Societal Transformation Delivery level: Not applicable
karl.resare@ri.se
/en/node/8686
More information:

Contact us for an initial dialogue on how we can contribute to your and Sweden's security.  

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Cybersecurity Sekundär områdes navigation:
Energy and electrification
Digital infrastructure
Risk and security
Tjänstetyp tagg: Provning

Analysis of Azodicarboxamide (ADCA)

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Analysis of Azodicarboxamide (ADCA) Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

It is important that the textiles on the market are free of harmful and regulated substances. Chemical analysis is a way to gain control over the products' chemical content.

Purpose/Benefit:

Azodicarbonamide, or azodiformamide is mainly used as a blowing agent in the rubber and plastics industry. Blowing agent in especially EVA and PVC.

The process can leave residues of formamide in the material, which is toxic for reproduction. ADCA may decompose into semicarbazide, a suspected carcinogen. 

Society and consumers set high demands on companies and their products. The legislation also means that you as an actor must have complete information and control over the chemicals in your product. It is especially important with products for children and goods with skin contact, such as clothes and accessories.

We can help you interpret the legal requirements in REACH and POPs and propose appropriate analyzes.

Method (what/which methods are used to perform the service):

OEKO-TEX analysis method.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Written report in Swedish or English.

Delivery time:

After order and arrival of sample material - normal delivery time is 10 working days.

Area:
Chemical and biological analysis
Textile
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Jenny Friedrichsen, Forsknings- och utvecklingsingenjör Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Divison (OLD): Division Materials and Industry Delivery level: Not applicable
jenny.friedrichsen@ri.se
/om-rise/hallbarhet/policydokument/personuppgiftsbehandling/behandling-av-kunders-och
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Chemical and biological analysis Sekundär områdes navigation:
Textiles
Risk and security
Health and life science
Tjänstetyp tagg: Provning

Analysis of extractable Heavy Metals

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Analysis of extractable Heavy Metals Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

It is important that the textiles on the market are free of harmful and regulated substances. Chemical analysis is a way to gain control over the products' chemical content.

Purpose/Benefit:

Extractable metals such as lead, arsenic, cadmium, mercury, chromium, cobalt and nickel should not be present in products. 

Society and consumers set high demands on companies and their products. The legislation also means that you as an actor must have complete information and control over the chemicals in your product. It is especially important with products for children and goods with skin contact, such as clothes and accessories.

We can help you interpret the legal requirements in REACH and POPs and propose appropriate analyzes.

Method (what/which methods are used to perform the service):

Analysis according to SS-EN 16711-2 and OEKO-TEX® STANDARD 100 M&ML-10.

This method is applicable to textile in any form (fibres, yarn, fabrics, etc.), leather materials as well as make-up, metallic and other accessories.

Analysis of Chromium (VI) according to OEKO-TEX OEKO-TEX® STANDARD 100 M-12.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Written report in Swedish or English

Delivery time:

After order and arrival of sample material - normal delivery time 10 working days.

Area:
Chemical and biological analysis
Textile
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Elham Franzén, Kemist Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Divison (OLD): Division Materials and Industry Delivery level: Not applicable
elham.franzen@ri.se,
/om-rise/hallbarhet/policydokument/personuppgiftsbehandling/behandling-av-kunders-och
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Chemical and biological analysis Sekundär områdes navigation:
Risk and security
Textiles
Health and life science
Tjänstetyp tagg: Provning

Certification of management systems for sustainable events - ISO 20121

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Certification of management systems for sustainable events - ISO 20121 Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

A certified event sustainability management system provides the conditions for effective and systematic sustainability work that adds value to the organization and its stakeholders. The standard is a powerful tool for meeting organizers, one-off events and recurring events of all sizes.

Purpose/Benefit:

Organizations that certify to ISO 20121 demonstrate both internally and externally that they are making an active choice regarding the sustainability management of their operations and the impact of their products and services on stakeholders and society.

The standard for sustainability in events is aimed at various venues and meeting and event organizers. The standard works for both one-off and recurring events. It is a management tool to guide how the organization's work is planned, implemented, monitored and continuously improved. It helps organizations to:

  • identify and reduce its impact on stakeholders and society
  • ensure compliance with legal and other stakeholder requirements
  • provide management with good control over the organization's impact on sustainability issues
  • set concrete sustainability targets for improvement to continuously monitor and evaluate environmental performance
  • continuously improve its sustainability performance
  • create sustainable business models
Method (what/which methods are used to perform the service):

An independent agreement with specific requirements for event sustainability management system certification is ensured through an initial audit, annual follow-up audits and recertification audits every three years. Follow-up audits are carried out during the event.

See description of the RISE management system certification process.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

When the organization meets the requirements for event sustainability management system certification according to ISO 20121:2024, a certificate can be issued.

Area: Certification Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Contact Certification
Lena Jönsson, Revisor
ISO 20121
Field measurements: No Price type: 1 Division: Do not use - Division Built Environment Preparation: No preparation required Standards:

Management systems for sustainable events - ISO 20121

 

Certification and marking: Management Systems Certification Type of service: Certification Instrument: Not applicable General area: Not applicable Order information: Se kontaktpersoner nedan URL: https://www.ri.se/en/certification-at-rise/management-system-certification/requ… Divison (OLD): Do not use - Division Built Environment Delivery level: Non-accredited
ceforsaljning@ri.se,lena.jonsson@ri.se
More information:

Find certified companies with management systems.

Link to Swedac website

The strong link between the research institute RISE and RISE Certification means that our auditors have the latest information in many areas. We have a clear mission from our owner to create a sustainable future and a competitive business community.

Contact us today to find out more!

3. Good health and well-being
5. Gender equality
8. Decent work and economic growth
10. Reduced inequalities
11. Sustainable cities and communities
12. Responsible consumption and production
13. Climate action
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Risk and security Sekundär områdes navigation:
Circular transition
Service innovation
Resource-efficient cities
Tjänstetyp tagg: Certifiering

CE marking of non-automatic weighing instruments, NAWI

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): CE marking of non-automatic weighing instruments, NAWI Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

Non-automatic weighing instruments placed on the EU market must comply with the requirements of Directive 2014/31/EU and bear the CE marking. RISE is a Notified Body under the Directive and performs the assessments required to verify that your product complies with the applicable regulatory requirements.

Purpose/Benefit:

With RISE, you receive an independent and recognized basis for the CE marking of non-automatic weighing instruments. We review the product and its documentation, issue the necessary certificates, and guide you through the process so that you can access the European market efficiently and with confidence.

About non-automatic weighing instruments

A non-automatic weighing instrument (NAWI) is a weighing instrument that requires the intervention of an operator during the weighing process.

The Directive covers, among other things, weighing instruments used for:

  • trade and commercial transactions based on weight
  • the calculation of taxes, customs duties, and fees
  • legal and governmental purposes
  • patient weighing in healthcare settings
  • prescription compounding in pharmacies
  • medical and pharmaceutical laboratories
  • direct sales to consumers
Method (what/which methods are used to perform the service):
  • Type Examination (Module B)

The manufacturer submits an application together with the technical documentation. RISE reviews the documentation and assesses whether the weighing instrument complies with the requirements of the Directive. Where harmonised standards are applied, these form the basis of the assessment. If the standards are not applied, RISE develops an evaluation plan in cooperation with the manufacturer.

If the weighing instrument meets the requirements, RISE issues an EU Type Examination Certificate. The certificate is normally valid for 10 years.

  • Quality System Assessment (Module D)

RISE assesses the manufacturer's quality system to ensure that production consistently complies with the requirements for the approved weighing instrument type. The assessment includes an initial review followed by regular surveillance activities.

Once the quality system has been approved, RISE issues an Assessment Decision. The certificate is valid for three years and is maintained through annual assessments.

  • Product Verification (Module F)

RISE verifies that manufactured weighing instruments conform to a valid type examination certificate. Verification may be carried out on each individual instrument or by statistical sampling.

If the product meets the requirements, RISE issues a Certificate of Conformity. This certificate provides the manufacturer with the basis for using RISE's notified body identification number together with the CE marking on the verified products.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

It is the manufacturer's responsibility to ensure that the weighing instrument complies with the requirements of the Directive and is correctly CE marked.

The manufacturer is defined as the person or organisation that places the non-automatic weighing instrument on the market under its own name, regardless of whether the instrument was manufactured by that person or organisation or produced on their behalf by another party.

Area: Certification Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Josefin Damberg, TIC-ingenjör
Nawi
Field measurements: No Price type: 1 Division: Do not use - Division Built Environment Preparation: Description of preparation Preparation information:

A first contact with Certification at RISE should be made as early as possible when a product is to be certified.

Our product certification services help you get the right conditions for a successful certification, understand the requirements and plan the process. Read more here

Link to order form: Certification rules and order of certification Standards:

RISE certification rule SPCR 306

Certification and marking: Product certification Type of service: Certification Instrument: Not applicable General area: Not applicable Order information: Application and order forms: URL: https://www.ri.se/sv/certifiering-pa-rise/produktcertifiering/certifieringsregl… Divison (OLD): Do not use - Division Built Environment Delivery level: Accredited
josefin.damberg@ri.se,
More information:

Do you need to CE mark a non-automatic weighing instrument? Contact us, and we will help you find the right path to CE marking.



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Metrology Sekundär områdes navigation:
Risk and security
Production and manufacturing
Tjänstetyp tagg: Certifiering

H2 SafeCert - personal certification for safe hydrogen installation

H2 SafeCert

New ways of using hydrogen are expected to be an important part of the green  transition, which means a rapidly growing market for hydrogen installations. In collaboration with several actors, RISE is investigating whether a personal certification for hydrogen installers can contribute to the development of the industry.

Coordinator
Completed
Hydrogen
One year
1 276 446
Division: Do not use - Division Built Environment

The demand and applications for hydrogen are expected to increase significantly in the coming years. Hydrogen will be distributed and made available via entirely or partially new applications such as refuelling stations, large storage facilities and other buildings connected to electricity generation, as well as in connection with new uses of hydrogen in production and laboratories. 
To get an idea of the scale of the growing market, the planned establishment of refuelling stations in Sweden can serve as an example. Today, there are only a handful of hydrogen refuelling stations in Sweden, but building permits or similar authorisations for at least 60 more stations are already ready. This, together with all other ongoing or expected hydrogen-related initiatives, means that the demand for personnel with the skills to carry out various types of hydrogen installations is likely to increase.

To ensure that future important hydrogen installations for a sustainable industry are done safely and that the right skills are easy to find, a documented check of the level of competence of installers can be a support.

The rules are being reviewed

The requirements for hydrogen installers are currently being investigated by MSB. In an earlier draft of general advice, the authority included the proposal for certification of hydrogen installers as a possible part of the upcoming update of the advice. In 2024, a new version of the proposed regulations will be put out for consultation.

Facilitating competency checks

A wide range of industrial actors are affected by hydrogen regulations and safety is a very important issue for the industry and crucial for the future role of hydrogen in the industrial transition. If a certification of hydrogen installers, or other type of competence check, is written into the general advice, or becomes an absolute requirement, it is important that the forms for this are clear as soon as the rules come into force.

To contribute to increased knowledge of policy-related obstacles and opportunities, the project will carry out a needs and impact analysis of a planned certification. The project will also develop a proposal on how the competence of installers can be checked and followed up using, for example, a personal certification.

Karolina Vikingsson

Projektledare
+46 10 516 55 37 Read more about Karolina
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Stina Wibom

TIC-ingenjör
+46 10 516 63 39 Read more about Stina

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9. Industry, innovation and infrastructure
12. Responsible consumption and production
Myndigheten för samhällsskydd och beredskap, MSB Nilsson Energy Energigas Sverige H2 Riskkonsult
Project end date: Hydrogen Sekundär områdes navigation:
Lifelong learning
Risk and security

Säker och optimal hantering av batterier från krockade fordon

CIRC-BAT
Transport cirkularitet

Projektet CIRC-BAT syftar till att etablera ny och utökad kunskap och lösningar som bidrar till en ökad cirkulär användning av batterier. Resultaten av projektet kommer att bidra till och påskynda en förändring mot säkra processer och effektiva värdekedjor bättre anpassade till cirkulära och hållbara system.

Deltagare
Completed
Cirkulär omställning
2 år
Division: Division Säkerhet och transport

Med ett växande antal elfordonsbatterier som produceras och släpps ut på marknaden finns ett ökande behov av cirkulära flöden för batterier från elfordon. Det är särskilt viktigt att se till att batterier och deras komponenter återanvänds och återvinns eftersom batterierna innehåller värdefulla och kritiska material som kobolt, litium och nickel som riskerar att bli en bristvara inom en snar framtid. Den stora utmaningen idag inom branschen gäller säkerheten vid hantering av batterier från uttjänta fordon. Det behövs ett säkert och effektivt process- och informationsflöde samt testutrustning och diagnosverktyg som kan utvärdera olika typer av batterier.

En hållbar och cirkulär värdekedja för elbilsbatterier minskar miljöpåverkan och reducerar uttaget av naturresurser för att upprätthålla en miljöbalans och samtidigt främja ekonomisk tillväxt. För att möta behovet av ökad cirkularitet och minskat resursuttag krävs en omställning av industrin och nuvarande värdekedjor. Metoder, verktyg och processer måste ny- eller vidareutvecklas för att säkerställa säker hantering och effektiva flöden i takt med ökad elektrifiering. Vidare behöver utmaningar relaterade till områden som informationsflöden och spårbarhet lösas. Ovanpå detta behöver ekosystemets aktörer tillsammans identifiera vägar för effektiv och ekonomiskt hållbar samverkan i ett transformerat system.

Genom studier och praktiska demonstrationer kommer projektet bland annat resultera i förslag till metoder för riskbedömning och riskminimering och ökad kunskap rörande de metoder, verktyg, riktlinjer och utbildning som behövs för att möjliggöra säkra, cirkulära och effektiva värdekedjor för batterier från elfordon.

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7.Hållbar energi för alla
12.Hållbar konsumtion och produktion
MRF (Motorbranschens Riksförbund) SFVF (Sveriges fordonsverkstäders förening) Borås Bildemontering AB Walters Bildelar AB Allbildelar AB Ådalens Bildemontering AB Jönköpings bildemontering AB Conbat AB IF skadeförsäkring AB Volvia, Stena Recycling AB Mobility Sweden AB Volvo Car AB SBR (Sveriges Bilåtervinnares Riksförbund Service) Stiftelsen Chalmers Industriteknik
Funders without URL: Re:Source Project end date: Batterier Sekundär områdes navigation:
Cirkulär omställning
Elektromobilitet
Risk och säkerhet
Material och beständighet

Cyberrisks caused by a flexible electricity market...

Case study of an energy island; COLA
"Krafttanken" in the city of Ludvika. A restored transformer, which is a part of the energy island.

In the future energy system, much electricity generation, flexible energy products and storage may be connected to the internet, making them vulnerable to cyber attacks. In this project, RISE and High Voltage Valley study cyber risks caused by a flexible electricity market and what can be done about the risks. The study is within an energy island.

Projektledare och koordinator
Active
Cyber security Energy Internet of Things Risk and safety Built environment Urban development
Region Dalarna
3 år
5 745 000 kr
Division: Do not use - Division Built Environment

The project name is Cyber risks caused by a flexible electricity market and what can be done about them: Case study of an energy island.

 Energy dependence is increasing and new energy sources such as wind and solar power do not deliver the same stability as existing electricity production, and therefore requires more flexible solutions. Connected user control is also increasing in a fast speed. The security policy situation has deteriorated drastically, which affects the threat picture.

Risk preparedness has primarily focused on specific systems and individual units on the electricity production side. The user side has not received the same attention, while flexible new solutions tend to be implemented close to the end users. Previous international studies have shown that cyber attacks from the user side can cause major disruptions.

Energy islands, created for security of supply, can be seen as a miniature of the entire electricity grid and are thus well suited to study the consequences of cyber threats. Through the project, we will get concrete and tangible results, which we can more easily communicate to everyone, from manufacturers to consumers.

Do you want to know more (In Swedish):

Krafttank används i forskningsprojekt för cybersäkerhet i elnätet | RISE

Cybersäkerhet i framtidens energisystem

In the RISE video Cybersecurity in the Future Energy system, we tell you more about how we can create a future energy system that is resistant to cyberattacks (the video is in English).

Contact for CiFE

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7. Affordable and clean energy
11. Sustainable cities and communities
16. Peace, justice and strong institutions
Here is a report that sheds light on cyber security for connected energy products.
Attach document: Project end date: Risk and security Sekundär områdes navigation:
Cybersecurity
Energy and electrification
Digital infrastructure

Risk assessment of Legionella in water systems

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Risk assessment of Legionella in water systems Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

The disease-causing bacterium Legionella is spread by inhaling aerosols from water systems, for example tap water in buildings. RISE offers help in assessing risks for the growth and spread of Legionella according to the requirements stated in the Drinking Water Directive chapter 10.

Purpose/Benefit:

Legionella is found naturally in soil and water. It currently causes between 100 and 150 cases annually in Sweden and is a growing problem. Outbreaks of Legionella are often linked to aerosol-forming water systems, e.g. cooling towers, showers, fountains, hot tubs and humidification facilities. In order to deal with Legionella in a water installation, the risks for growth, survival and spread need to be mapped and an action plan drawn up.

The new Drinking Water Directive states that there must be a risk assessment of Legionella in water systems in society important and prioritized buildings. According to the directive, prioritized buildings mean large properties that have many users who may be exposed to water-related risks. More specifically, it can, for example, be:

  • Premises related to health care and social care
  • Teaching premises
  • Airports and ports
  • Hotels
  • Sports facilities
  • Swimming facilities
  • Multi-apartment buildings
  • Assembly premises
  • Premises for correctional facilities

In addition, a risk assessment should be carried out in premises and facilities that previously had problems with Legionella.

Method (what/which methods are used to perform the service):

The projects are structured as a traditional risk analysis according to Codex Alimentarius/FAO, 2014 (or equivalent) with the steps:

  1. Hazard identification 
  2. Hazard characterization 
  3. Exposure estimation 
  4. Risk characterization

The risk assessment can be done theoretically and/or with the support of measurements. For this, RISE offers, among other things, sampling of the customer's water system, microbiological analysis, as well as tests in labs and pilot systems.

The focus of the work is adapted to the current issue and the customer's needs. The risk assessment can be expanded and supplemented with action analysis and action proposals.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

The risk assessment is summarized in a report and presented in a meeting with the customer.

Area:
Construction
Infection control
Climate adaptation
Chemical and biological analysis
Food
Public sector
Risk and safety
Total defence and crisis preparedness
Water
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Charlotta Löfström, Senior Forskare
Faucet
Field measurements: Yes Price type: 1 Division: Division Bioeconomy Preparation: No preparation required Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Order via the contact persons Divison (OLD): Division Bioeconomy Delivery level: Not applicable
charlotta.lofstrom@ri.se
/en/node/9711
3. Good health and well-being
6. Clean water and sanitation
9. Industry, innovation and infrastructure
11. Sustainable cities and communities
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Water Sekundär områdes navigation:
Built environment
Construction
Risk and security
Infection control
Tjänstetyp tagg: Konsultuppdrag

Software for medical devices, IEC 62304 / AMD1

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Software for medical devices Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

The majority of medical devices used today contain software in some form. This in turn places various requirements on the software, regulated in standard IEC 62304. RISE can assist in evaluating that the requirements of this standard are met. 

Purpose/Benefit:

IEC 62304 contains processes, activities and tasks that together create a common framework, necessary for medical device software to maintain an acceptable quality throughout the life cycle of the medical device.

The standard is relevant to the development and maintenance of medical software when the software itself is a medical device or when the software is an embedded or integral part of the final medical device.

This standard does not cover validation and final release of the medical device, even if the medical device consists entirely of software.

RISE can assist in evaluating that the requirements of this standard are met. The reason for taking help from RISE can be both to get help from us to build up your internal competence in the area or that you have a customer who requires you to be able to show that an independent organisation has evaluated your product's software.

By taking help from RISE early in your product development, you avoid the risk of interpreting these frameworks incorrectly. 

Method (what/which methods are used to perform the service):

The evaluation is based on our Swedac accredited methods for:

  • IEC 62304:2006 / AMD1:2015, “Medical device software”
  • IEC 82304-1:2016, “General requirements for product safety”. (For products used without dedicated hardware
Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

The results of the RISE evaluation are summarised in an accredited RISE report.

Avaliable courses

Course on medical device software

Area:
Cyber security
Medical devices
Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Ted Strandberg, Projektledare
Anithasree Maroju, TIC-ingenjör
Software medical equipment
Field measurements: Yes Price type: 1 Division: Division Safety and Transport Preparation: No preparation required Standards:

IEC 62304

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Antennas General area: Not applicable Order information: Order by contacting us Divison (OLD): Division Safety and Transport Delivery level: Accredited
/en/personal-data-processing/candidate-database
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Cybersecurity Sekundär områdes navigation:
Digitalisation
Risk and security
Tjänstetyp tagg: Verifiering och validering