Preclinical research

Effectiveness and safety are the most important factors/points during the (preclinical) development of medical devices. Even in prototypes the correct functionality is audited in context of design verification and product validation. Testing during development finds possible problems early and enables a fast assessment of conformity.

Necessity and benefit of the usability of medical devices are often underestimated. At the same time a deficient usability often leads to reclamations, incidents or a lack of customer interest.

Safe products and happy users – those are the goals of usability. User friendliness and ergonomics are important quality features becoming increasingly important for medical devices. Simultaneously there is a regulatory obligation to optimise usability.

Medical devices must be designed and produced in a way that reduces user error as much as possible. The process of usability is described in the norms EN 60601-1 and EN 62366.

Elements of the process of usability are process analysis, the risk analysis as well as specification, verification and validation of the usability. These are documented in the usability file. Don’t be intimidated by the complex setup of the usability file, come and see us. We’d love to consult and support you during all your questions regarding the usability file.

• Creation of sophisticated testing plans
• Execution of tests in-house
• Creation of the usability file

Medical devices must be developed in a way that a safe and working product emerges at the end. This needs to be proven by the design verification and product validation – as it is demanded by international regulatory requirements.

Design verification checks whether the device meets the specified requirements. Product validation on the other hand checks whether the intended purpose is fulfilled. This includes usability.
Even if both examinations seem similar, products can fullfill the requirements of the specification without fulfilling their indented purpose.

Therefore, early verification and validation measures contribute to prevent delayed market release, recalls or warranty claims.

• Together we develop a target oriented strategy for your design verification and/or product validation
• Efficient project implementation
• Clear documentation