Regulatory Pathway is $1,500.00
Service Fee Includes the Following:
- 20-30 minute conference call via a Zoom meeting (will be recorded to ensure no information is forgotten) to discuss product description, including the indications for use, and the desired markets for regulatory approval (i.e., USA, Europe and Canada) – Please schedule a 30-minute meeting using my Calendly link; confirmation will include an updated invitation with a link to join a Zoom session
- 4-8 hours of preparation determining the regulatory requirements for each desired markets, identifying testing requirements for verification and validation, identifying special controls guidance documents, identifying potential predicate devices for a 510(k) submission and developing a recommending with regard to the optimum sequence of regulatory submissions for earliest product launch
- 45-60 minute presentation via Zoom (will be recorded in order to allow replays) to discuss the final regulatory pathway analysis and next steps in the verification and validation process and/or the regulatory submission process – this will be scheduled by Rob Packard during the previous 20-30 minute conference call
Click Here to read more about this service.
This is a pre-paid consulting service. You should already have scheduled your preliminary consulting call for 30 minutes in order to review the details of your new product and the markets you are interested in obtaining regulatory approval for. You should also have scheduled the final consulting session where Medical Device Academy will be presenting our Regulatory Pathway Analysis live.