For reusable medical devices, there must be a validated Instruction for Users (IFU) for cleaning and disinfection. We assist in creating a functional instruction according to both ISO 17664-1 and ISO 17664-2 and validate that the products are properly cleaned and disinfected.

It is crucial to follow ISO 17664-1 and ISO 17664-2 as these standards ensure that medical devices are handled in a way that minimizes the risk of infections. Proper cleaning and disinfection are essential to prevent the transmission of harmful bacteria to patients.

By adhering to these standards, manufacturers and healthcare providers can guarantee that products are safe to use and meet regulatory requirements, such as those outlined in the MDR.

This strengthens trust in the quality and reliability of the products, while contributing to enhanced patient safety.

The cleaning procedure is validated by soiling the product with appropriate contaminants, such as blood or artificial soil, followed by cleaning and analysis of any remaining soil residues through methods such as protein analysis or hemoglobin analysis, according to ISO 15883-5 (MDR) or ANSI/AAMI ST98 (FDA).

We can also evaluate automatic (thermal) disinfection with temperature probes to ensure that the product meets the expected A0 value, according to ISO 15883-1 (MDR). Manual (chemical) disinfection processes are validated according to ANSI/AAMI TIR12 (FDA).

Methods and results are presented in a written report, in Swedish or English.

RISE offer in vitro-analyses to study interactions between material/subtances and cell lines.

Many are the reasons to study the effect of substances or materials on cells. It can be materials/substances to be used in or as medicinal products, wound dressing, future pharmaceuticals, supplements etc. Depending on what the product are to be used as, different evaluations are of interest. With vast knowledge in cell and molecular biology we will adjust the evaluation to the customers needs. We bring in new cell lines and methods on an ongoing basis. 

If the customer lacks the laborative resources we will assist with that, but we also have the ability to take on a bigger role in your developmental journey. 

Frequent methods may include but not be limited to; toxcicity, proliferation, gene expression, protein analysis and morphology studies based on microscopy. We will aslo help with more uniqe evaluation methods including proof of concept and mode of action. 

If the customer have a protocol or method, we gladly help you evaluate, troubleshoot and validate it. 

By studying your substances or materials in vitro before going in vivo you will save both money and research animals in the process by choosing the best candidates earlier in the testing. If your method is new, repetition and validation by an independet laboratory open up new posibilities for it. 

Method to be used is completely depending on the customers question. If you have questions regarding cell biology you are welcome to schedule a meeting to discuss your uniqe perspective. We can help with everything from questions, experimental design and performance to interpertation of results. Please contact us for more information regarding how we can help you. 

The customer get a report with parameters of choice. 

Deliverytime depends completely on methods used and whats to be studied. Generally it takes two weeks to start up cells from cryopreservation. In addition to that there is time needed to set up and performe studies of choice. The total time from tender acceptance is around six weeks. Contact us for more specifics. New cell lines, methods and national holidays will affect the delivery time. 

Contact one of the persons listed below for dicussion or price 

Information regarding test subtstance need to be discussed before start of cultivation of the model systems. The test substances need to arrive one week before test start.

Knowledge about a material´s mechanical properties and behaviour when subjected to loading is needed in order to demonstrate the applicability of the materials for a specific task.

Biomechanical characterization of a sample using a test protocol tailored to the needs of the customer and prerequisites of the application in question.

Characterization of tissues and other materials mechanical properties and behaviour when subjected to loading is crucial in order to determine theirs limits and the effects of a certain treatment on the material. This is critical when it comes to determine the applicability of a material or process for a specific application.

We offer material and tissue analyses controlling load, displacement, frequency and loading profile in order to characterize for example different mechanical properties such as anisotropy and/or nonlinear stress-strain relationships. Besides regular testing in tension, compression, 3-point bending and ring strength, we adapt the test method to the material and implement new test methods upon request. We offer analysis with quality assured equipment selected with regards to the material/tissue type and test method.

The method and analysis results are typically delivered in the form of a testing report unless otherwise agreed but can also be prepared for online publication in scientific journals.

Analysis can be done in accordance with specific standards upon request. We also assist in reviewing and identifying appropriate standards.

Analysis of endotoxin levels is a crucial part of quality control in biotech, medtech, and pharmaceutical industries. An accurate and precise analysis can help reduce the risk of adverse effects and ensure high quality and safety of biological products.

Endotoxins are components of the outer cell membranes in gram-negative bacteria and when released, can cause serious and sometimes deadly inflammatory reactions in humans and animals. Therefore, it is important to ensure that medical devices, biological and pharmaceutical products and materials are free from endotoxins before use.

At RISE, endotoxin levels are analyzed using a kinetic chromogenic Limulus amebocyte lysate (LAL) method according to Eur.Ph.2.6.14 (method D). The LAL test is based on the coagulation reaction of amebocytes from horseshoe crabs, which react with endotoxins. The test is sensitive and specific for endotoxins and can detect very small amounts.

For the analysis, the Endosafe® LAL-cartridge system from Charles River Laboratories, with FDA-licensed cartridges and the Endosafe® Nexgen PTS™ reader is used. The detection limit for the analysis is 0.005 EU/mL.

We can analyze both liquid solutions and solid materials, e.g. medical devices. Solid materials are extracted according to US Pharmacopoeia chapter 161.

The results are presented in a report with an overview of the detected levels in each sample.

Contact us for price information. Please find contact information below.

Both solid and liquid samples can be prepared and analysed.

We help inventors and multinational industries with prototyping in flexible electronics.

Flexible electronics encompasses all materials which are flexible, stretchable, thin -  such as PET, leather, paper, TPU and more. Conventional electronics is typically mounted on rigid PCBs, which hold certain design limitations. To create smaller, smarter, lighter and more ecofriendly systems we use printing as a manufacturing methodology to create electronic and iontronic systems. By combining integrated circuits with flexible substrates we get the best of two worlds: hybrid electronics.

We support both inventors and industrial clients:

• FTO (Freedom to Operate)
• Market studies
• Design and electronic design
• Soft- and hardware design and selection
• Printing
• Integration
• Material selection
• Integration
• System design
• Prototyping
• Small series production to verify scalability
• Lighter
• Smaller
• Low power circuits and systems
• Eco-friendly
• New form factors
• Possibility to trial in small scale
• Using leading scientists
• Advanced Open Labs - we operate a state-of-the-art facility (Printed Electronics Arena, PEA) which is the hub in the Swedish Innovation Cluster in Printed electronics

All we do is aimed at industrial scaling. We use multiple production methods such as screenprinting, inkjetting and offset printing and in our labs we have several ways to cure, dry and analyse results. Furthermore we can mount integrated circuits and chips onto flexible substrates.

We print antennas, diodes, transistors, sensors and displays and when additional computational power is needed we combine silicone based chips with printed components.

Anything from single prototypes to small series (<50.000 units). 

Components which we typically manufacture:

• Passive humidity sensors
• Piezo sensitive materials and sensors
• Electrochromic displays (RISE ECD)
• Electrochemical Transistors, organic (OECT (Organic Electronic Chemical Transistors)
• Test series for novel inks, electrolytes and dielectrica
• Biosensors (UV, glucose and several more in confidential projects)

Depends on complexity level.

Not applicable.

Do you manufacture or distribute medical devices in Europe? If so, you must comply with the MDR and IVDR. RISE certifies your management system to ISO 13485 – an accredited route to regulatory compliance that gives you credibility with authorities, customers and partners.

ISO 13485 is the international standard for quality management systems in the medical device industry. Certification demonstrates that you work in a systematic and structured manner to meet both customer and regulatory requirements. It confirms that your processes are controlled, traceable and quality-assured, which instils confidence in your entire way of working and contributes to the high quality of what you deliver.

Manufacturers of medical devices are responsible for ensuring that the product is safe and suitable for its intended use. By implementing a quality management system in accordance with the standard, you comply with the relevant parts of the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).

Benefits of certifying your management system: 

• Ensures that you comply with the relevant provisions of the MDR (2017/745) and the IVDR (2017/746)
   
• Increases confidence among authorities, customers and partners
   
• Creates clear processes that reduce risks and improve product quality
   
• Facilitates market access within the EU and globally
   
• Demonstrates that you take responsibility for patient safety and quality

See the description of the RISE certification process for management systems.

Our audits are characterised by innovative thinking and a constructive, open dialogue that provides you with new perspectives, contributes to the development of your business and builds greater trust among your customers. At the same time, you benefit from a reliable and stable service accredited by SWEDAC, backed by many years of experience and expertise within the organisation.

With RISE as your certification body, you gain a partner to grow with. We also offer certification of management systems for quality, the environment and occupational health and safety, as well as a wide range of other certification services covering management systems, products, companies and individuals. RISE can provide a comprehensive solution for you in this field.

Contact us to find out more!

We help you understand how people actually use your product, service, or environment—and how you can make it better.With over 20 years of experience, flexible working methods, and one of Sweden’s most advanced UX labs, we deliver insights that reduce risks, save time, and lead to solutions that work for more users.

How do you know your product works for everyone? Understanding the user and their needs is essential for success. Through qualitative and quantitative methods—such as interviews, usability tests, expert evaluations, focus groups, and surveys—we provide needs assessment and actionable insights to ensure strong usability and user experience (UX).

To find out how we can work together, submit your interest today via the form on the right—or read on to learn more.

Step inside one of Sweden’s most advanced UX labs, where expertise, technology, and real users come together to test and improve everything from appliances and medical devices to apps and public services.
With live streaming, screen mirroring, multiple camera angles, and real-time analysis, you get immediate answers—whether you’re on-site or participating remotely.

Watch the movie from our lab here: https://www.youtube.com/watch?v=2HRs9NjdHwE

Understand the User

We help you deeply understand the user’s needs, behaviors, and challenges. By combining observations, interviews, and testing—in our lab, in the field, or in users’ own environments—we uncover details that are easily overlooked and provide a solid foundation for decision-making.

Test That Matters

We focus on evaluating what truly determines your solution’s success. Using methods that deliver clear, measurable results, we test everything from early prototypes to finished products and complex environments—both physical and digital.

Create Solutions That Work

We translate insights into concrete recommendations and support you in implementing improvements. Our work is always tailored — from intensive one-day test sessions to long-term user studies and development partnerships.

Independent Expertise—from Start to Final Solution

As an independent research institute with a user-centered focus, we create foundations that empower you to develop functional, user-friendly products and systems that meet users’ needs and expectations.

We support you throughout the entire process — from needs assessment and choosing the right method to conducting studies, analyzing results, and providing actionable recommendations.
Our experts bring extensive experience, and you can confidently hand over the entire process or parts of it to us.

We work closely with our partners, fostering long-term collaborations that enable fast and agile processes while supporting continuous learning within the organization.

Methods That Provide Answers

We use proven, standardized methods to measure usability and understand the user experience:

• Usability testing and expert evaluations
• Observations and field studies
• Focus groups and surveys
• Long-term studies such as diary studies and home visits

Testing can take place in our lab state-of-the-art UX lab —specifically tailored and equipped with the latest technology. Tests can be livestreamed or observed behind one-way mirror. We also work in the field—on factory floors, in homes, health centers, vehicles, and other environments.

The results are analyzed and compiled into clear, actionable recommendations that support decision-making and further development. We can also deliver high-quality video footage, edited into clear summaries for communication and presentations.

One of Sweden’s Most Advanced UX Labs

What you gain access to:

• 360° cameras, live streaming & recording
• Screen mirroring & prototype mirroring
• On-site and remote observation
• Adaptable test room with props
• Control room & observation room
• Access to experienced test leaders and analysts

We Work Where the Users Are—Across All Industries

• Consumer products
• Medical technology
• Education & training
• Public sector
• Automotive & manufacturing
• Health & care
• Hospitality
  …and many more, both locally and globally.

Eliminate Guesswork—Get Answers You Can Trust

We help you make confident decisions and create solutions that reach more people by working:

• Independently
• Evidence-based
• User-centered

According to agreement.

ISO 9241-11

New materials give soft electrodes (Swedish)

Interfaces in Organic Electronics

LiU, LOE introduction film