US Regulatory requirements
C-REG Medical brings you close support to comply with the FDA regulatory requirements
Where are you with the US market ? Whether you are just thinking about selling your device on the US market or actually working hard on the project already, a high-level experience allows me to respond to your needs.
I can intervene on a large range of subjects :
- assisting you in understanding FDA requirements for Q-Subs, 510(k), deNovo, PMA submissions
- identifying the correct FDA product classification
- determining which guidance documents and standards are applicable
- completing your submissions on your behalf or reviewing your draft submissions
- offering guidance on development of labeling (User Manual, Software, Labels, Commercial brochures...)
- advising on compliance with QSR (Quality Systems Regulations) : 21 CFR 820
- organising clinical studies for FDA submissions
- preparing for FDA Foreign & USA based inspections
- communication with the FDA
- help you achieve compliance of your software development process with regards to FDA requirements.
- guidance for completing a Risk Analysis according to ISO14971
- guidance for implementation of post-production vigilance systems, including vigilance systems for users, distributors and subsidiaries.
Have you thought about training ?
Your regulatory issues could be first addressed by training your team involved in the FDA project.
Any
training program will be tailored to your needs, taking the team profile into account.
For more details or to discuss other projects, please contact C-REG Medical.