Medical device import and distribution

Import and distribution link requirement and supplier acceptance to device files and market-access evidence within establishment responsibility.

Suggested package

The ISO 13485 package for the quality of medical device import and distribution.

Medical device quality

Example package index

One medical device import and distribution quality package example contains 169 documents, counting the system manual once. Your answers determine your order’s index and count.

1. M-01 Device quality system, responsibility boundaries and process interaction
2. POL-01 Management system policy
3. P-01 Document and record control
4. P-02 Management review
5. P-03 Competence, training and awareness
6. P-04 Infrastructure, work environment and storage conditions