Product Development as described and established Process is integral part of the required Quality Management System in your company. A new R&D project starts with the definition of ALL User Requirements / Customer Needs. This is a must and ‘not written is not done'...
It helps a lot to fix in the very early stage already the Intended Purpose (Mode of Action) and the Indication (Clinical Use) of the new medical device. The proper translation of the User Requirements into Development Specifications (system + separately components) is often a challenge...
- Get your medical device CE marked or FDA approved. - Generate a MDR -compliant Technical Documentation. - Get rid of a Major Finding from the last audit or even a 483.