Startup not yet trained in the typical procedures.
For Startups not yet trained in the typical procedures, it is necessary to get a product to the market. You need Regulatory Support what to do to get your product idea into the market…
- Did you already define the Intended Purpose of your product?
- Did you check with your Notified Body the classification of your medical device?
- Is the conformity assessment procedure already fixed?
- Do you have a Quality Management System according EN ISO 13485 in place?
- What is a critical supplier, and did you already audit them?
- How to complete a Technical Documentation?
- How to find the right template and the right guidance document for writing a 510(k)
- How to choose the Predicate Device?
These are important questions with potentially unsolved issues. We can give advice and / or our support to solve these issues.
We share our experience from more than 35 years medical device business (class I / IIa / IIb / III; combination products).
