As the design begins to take shape, the product must be manufactured and tested on a smaller scale. Pilot manufacturing enables evaluation of design, material selection and production methods before scaling up. We support prototype development, small-scale production and design optimisation. Using modern technical infrastructure, we can manufacture and test products using several technologies, including printed and flexible electronics, biosensors and other advanced components.

• Prototyping and pilot production in flexible and hybrid electronics | RISE
• Surface analysis - a useful tool for your applications | RISE
• 3D-Bioprinting and additive manufacturing | RISE

Preclinical evaluation is a key step in demonstrating that a medical device is safe and functions as intended before clinical studies begin. We provide testing and analysis within biology, biochemistry, bioanalysis and toxicology to evaluate product safety, performance and material properties. This may include biological evaluation according to ISO 10993, risk management according to ISO 14971, and toxicological assessments. We conduct analyses both in vitro and in vivo and can also support interpretation of results and recommendations for further development.

• Biological evaluation of medical devices according to ISO 10993 | RISE
• Toxicology - for maximised safety | RISE
• Biochemistry and bioanalytical chemistry | RISE
• Biomechanical tissue analysis | RISE

If the product contains an active compound that needs to be formulated, RISE can assist with the development: Formulation science and technology | RISE. RISE can also evaluate products based on antimicrobial peptides: Products based on antimicrobial peptides | RISE

For reusable medical devices, RISE can validate the processes in the instructions for use regarding cleaning and disinfection, as well as sterilization according to different standards depending on application to MDR or FDA.

RISE can also assist with microbiological analysis, such as bioburden, as well as evaluation of packaging, accelerated aging, shelf-life and transport testing.

To comply with MDR requirements, medical devices must demonstrate clinical evidence of safety and performance.

We support the planning and documentation of clinical evaluations and clinical investigations in accordance with regulatory requirements. This includes study design, documentation, reporting and regulatory compliance.

Technical documentation is a central part of medical device development and is required before CE marking.

We help structure and prepare documentation in accordance with MDR Annex II, including product description, product specifications, compliance with General Safety and Performance Requirements (GSPR), risk management documentation, and verification and validation data.

We can also support work related to electrical safety, electromagnetic compatibility and software according to IEC 62304.

As development approaches its final stages, the product must be prepared for regulatory review and market launch.

We help prepare your submission to a Notified Body for MDR certification, manage regulatory questions and support updates to technical documentation.

For certain types of medical devices, RISE can offer small-scale production, for example through our centre for printed electronics:
Prototyping and pilot production in flexible and hybrid electronics | RISE

Digital technologies are playing an increasingly important role in medical devices. Data analytics, AI, IoT and smart sensors can enable new functionality, improved usability and stronger clinical decision support.

We support the development of digital and connected medical devices — from system design and integration to testing and verification in accordance with relevant standards.

• AI in Medicine | RISE
• Implementation of digital solutions and new ways of working in health | RISE

Accurate measurements are a prerequisite for the development of medical technology. As experts in quality‑assured measurement technology, we assist with all aspects of measurement, from flow and dimensional measurements to electrical measurements. 

• The National Laboratory for Volume and Flow

If you have a product or service that focuses on meeting the needs of assistive devices for people with disabilities, we can help with its assessment and design. In addition to optical measurement equipment and associated laboratory facilities, RISE also has equipment for measuring basic acoustic properties in a room or environment, as well as for assessing hearing in individuals.

• Audio-visuell perception in particular for sensory deprivation

RISE offers controlled user studies of media services, covering both screen and video quality, as well as lighting measurements in, for example, medical applications.

• Experience and measurement of Visual Media Quality

We offer services in both sound and vibration measurements for medical devices, for research and development as well as certification purposes. Our measurements are primarily based on the standards ISO 11201:2010 and ISO 3744:2010, for which we are accredited, but we can also perform measurements according to product‑specific standards upon request:

• Acoustic properties of medical devices 

We also assist you with testing and evaluating usability, ergonomics, and user experience (including usability) in accordance with ISO 9241‑11 and IEC 62366‑1.

• User studies for increased user experience and usability

How do I choose the right manufacturing process for my medical device?

The choice of manufacturing process depends on the product design, materials, production volumes and regulatory requirements. We help evaluate options such as prototype development, flexible electronics, additive manufacturing and small-scale production — with a focus on quality, scalability and cost efficiency.

When should pilot manufacturing begin?

Pilot manufacturing becomes relevant when the concept has been verified and production, materials and performance need to be tested in smaller batches. It is an important step before clinical evaluation and future scale-up.

What is included in preclinical evaluation?

Preclinical evaluation includes testing safety, biological compatibility and functionality before clinical studies begin. This may include biological evaluation according to ISO 10993, risk management according to ISO 14971, toxicological assessments and GLP-based analyses.

How are clinical evaluation and clinical investigations conducted?

Clinical evaluation demonstrates that a product meets MDR requirements. This may involve literature reviews, clinical data or clinical investigations. We support planning, documentation and reporting according to applicable regulations.

What is required in technical documentation under MDR?

Technical documentation according to MDR Annex II must include product description, compliance with GSPR requirements, risk management documentation, verification and validation data, as well as preclinical and clinical evidence. A correct structure is essential for review by a Notified Body.

How do I prepare my product for CE marking?

CE marking requires compliance with regulatory requirements, correct documentation and — for higher risk classes — review by a Notified Body. We support preparation, documentation updates and regulatory dialogue.

Can you also support digital and connected medical devices?

Yes. We provide support in digitalisation, including IoT, smart sensors, data analytics and software-related requirements according to standards such as IEC 62304.

In the first phase, we can support you with technology scouting, identification of key functions in your idea, formulation of concept solutions, definition of product specifications and development of a project plan moving forward.
Business Development | RISE

We help you determine whether your product qualifies as a medical device and identify the appropriate classification under the MDR. More advanced solutions may lead to a higher classification. It is also important to analyse the intellectual property landscape for the technology you plan to use. RISE has extensive experience supporting clients in developing an IP strategy together with legal experts.

At this stage, companies typically need to evaluate funding opportunities and define their business strategy. This includes identifying target markets, exploring procurement and reimbursement possibilities, securing intellectual property assets and identifying suitable collaboration partners.

Based on existing solutions and what makes your idea unique, we can begin simulations of critical components, select appropriate technologies and develop proof-of-concept solutions to evaluate the best path forward. If you plan to patent your solution, this is also a good stage to prepare a first patent application draft together with a legal expert.

During the continued development of your product concept, we gradually build prototypes together and establish your first Bill of Materials (BOM). We explore possible manufacturing methods and discuss suitable suppliers. If a patent application has been prepared, this is typically the stage where it can be submitted.

We can also validate key functions in the laboratory and conduct exploratory feasibility studies and user studies using design and functional prototypes.
Prototyping and pilot production in flexible and hybrid electronics | RISE

A needs assessment is the starting point of a successful project and forms the basis of the usability engineering documentation and user requirements needed to ensure usable, efficient and safe end products and services according to IEC 62366-1. We can also help evaluate user requirements throughout all development phases according to relevant standards.
User studies for increased user experience and usability | RISE

A Quality Management System (QMS) is required for product approval. It is recommended to follow ISO 13485. We can support in implementing such a system early in the product development process.

We can also certify the system according to ISO 13485: Medical device management system certification - ISO 13485 | RISE

If you are considering implementing digital solutions, we offer a range of expert services to support you.

• Implementation of digital solutions and new ways of working in health | RISE
• Digital transformation contributes to the elderly care of the future | RISE
• AI in Medicine | RISE

RISE can help you evaluate and improve the environmental footprint of the product:

Test methods for safe & sustainable healthcare products | RISE

What counts as a medical device?

A medical device is a product used to diagnose, prevent, monitor or treat disease or injury. Classification is governed by the EU Medical Device Regulation (MDR EU 2017/745) and depends on the product’s intended purpose and risk level.

How do I know which risk class my product belongs to?

The risk class (Class I, IIa, IIb or III) is determined according to MDR rules and affects requirements for clinical evaluation, technical documentation and potential review by a notified body. Correct classification early in development is crucial.

When do I need a Quality Management System (QMS)?

A QMS according to ISO 13485 should be established early in development. It facilitates documentation, risk management and future CE marking while reducing the risk of delays.

What do verification and validation mean?

Verification ensures that the product meets technical requirements and specifications. Validation confirms that the product fulfils user needs and intended use. Both are essential steps before CE marking.

Do I need to consider patents and IP early?

Yes. An early analysis of intellectual property and existing patents reduces the risk of infringement and strengthens your ability to protect your innovation.

Can you help with CE marking?

We support work with technical documentation, risk management, classification and regulatory preparation according to MDR – key steps towards CE marking.