Medical device quality
ISO 13485
Design and production controls, traceability and medical-device requirements.
Medical device authorized representative
Representation links the mandate and manufacturer and device boundaries to communication, submission, reporting and follow-up.
Suggested package
The ISO 13485 package for the quality of authorized representation for medical devices.
Example package index
One medical device authorized representation quality package example contains 169 documents, counting the system manual once. Your answers determine your order’s index and count.
- M-01 Device quality system, responsibility boundaries and process interaction
- POL-01 Management system policy
- P-01 Document and record control
- P-02 Management review
- P-03 Competence, training and awareness
- P-04 Infrastructure, work environment and storage conditions
Packages for your sector
Prices in Saudi riyals, VAT included, for a package in one language; the price for both languages shows when you order.