Medical device product development

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.

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.

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

Clinical evaluation may be based on clinical data, literature studies or clinical investigations. We support the planning, execution 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, software and electromagnetic compatibility according to relevant standards.

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, we can also offer small-scale production, for example through our centre for printed electronics.

Digital technologies are playing an increasingly important role in medical devices. Data analytics, artificial intelligence, 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.

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.