Training programs

Getting some knowledge about foreign regulations makes it easier to implement standards and directives...

C-REG Medical can intervene at your site to provide training to the personel involved in the project(s).
The training programs are tailored to your needs, considering both time and the personels' knowledge.

Here are examples of training programs already set up:

• CE marking for manufacturers of medical devices (93/42/CE)

• Updating of CE files in accordance with the 2007/47/CE

• CE marking for manufacturers of medical devices for in-vitro diagnostic (98/79/CE

• Quality systems obligations (ISO9001, ISO13485, 21 CFR 820 - QSR)

• Internal Auditor (ISO 9001, ISO 13485, 21 CFR 820 - QSR)

• Development process and compliance with ISO 9001, ISO 13485, 21 CFR 820 - QSR

• Introduction to the FDA for manufacturers of medical devices

• Managing the preparation of a 510k submission to the FDA

• ...

Do not hesitate to contact me to discuss your needs.