IntroductionStartup 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 timetomarket.

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.

Regulatory clarification

Determination of the device class and regulatory pathway.

Authority Approval

Handson experience with both Notified Bodies and FDA approval processes of medical devices and combination products.

Documentation Level

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.

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