Performance and safety are the most important factors in the (preclinical) development of medical devices. The correct functioning is therefore checked in the prototype. Testing during development can reveal possible problems even before the design freeze. This saves time and money and paves the way for a speedy conformity assessment. With our scientific expertise, we work with you to develop appropriate test plans, carry out in-house tests and prepare the corresponding documentation.
The necessity and benefit of usability testing of medical devices are often underestimated. The lack of usability often leads to complaints, recalls and even incidents. Usability tests reduce risks associated with the use of the product. User-friendliness and ergonomics are important quality features of medical devices. Considered at an early stage, the fulfullment of a regulatory requirement thus becomes a competitive advantage.
Don't let the complexity of a usability file deter you. Reach out to us. We will advise and support you in all questions concerning usability.
- Experience in preclinical research and product development
- Knowledge of regulatory requirements and their pragmatic implementation.
Cooperation with novineon CRO supports you already in the pre-clinical phase – from the planning of verifications and validations to efficient execution and high-quality documentation.
Contact your novineon specialist.
Phone: +49 (0)7071/98979-124