AD-HOC REGULATORY SUPPORT FOR SMALL COMPANIES
IntroductionStart–up companies are often based on a high technical knowledge, rather thananinterest in the regulatory area. Our experience is,that if you in your early developmentprocessdeterminethe regulatory requirementsand strategyfor the device, you will reduce the number of surprises later on in your development process, and reduce your time–to–market.
P4E QA offers you supportin the early stages of your product development, and it does not have to be expensive. We can give preliminary regulatory advice, and you only pay for the hours you use.
Determination of the device class and regulatory pathway.
Hands–on experience with both Notified Bodies and FDA approval processes of medical devices and combination products.
Preparation of thousands of documents has given usa solid knowledge of the required content of documents.
Basic Quality Requirements
Determination of the required quality level is essential for profitable production.