To implement this system you don't have to be an expert in ISO 13485 or 21 CFR 820,
but you have to know your company and have a basic understanding
of quality management systems. To assist you, the package includes:
- Employee training booklet (24 pages) to introduce you to the basic concepts of ISO 13485 and 21 CFR 820.
- A tutorial built in to the documentation to help you customize the documents to
fit your company (blue italic notes, comments, and tips);
- A tutorial built in to the Internal Audit and Gap Analysis Checklist ('What to look
for and how' column);
- Pictorial instructions (tutorials) to teach you how to use the software.