What do you recommend me in terms of elaborate an implementation plan?
The first step of the implementation plan is to adapt your current company’s QMS to the type of medical devices that your organization will be dealing with such as the inclusion of medical device files, design and development file, software validation and sterilization process just to name a few.
Here are the steps to successful implementation of ISO 13485:
1) Get management support.
2) Identify requirements.
3) Define the scope.
4) Define processes and procedures.
5) Implement processes and procedures.
6) Deploy training and awareness programs.
7) Choose a certification body.
8) Operate the QMS / Measure the system.
9) Conduct internal audits.
10) Conduct a management review.
11) Take corrective action.
12) Perform the stage 1 certification audit.
13) Stage 2 certification audit.