The quality of the products we develop, design and manufacture is assured by the management commitment to the stringent compliance with one or more of the following Quality Systems:
ISO13485:2016
21 CFR 820
MDSAP
Based on our knowledge and experience we can assist you in a practical way in the following areas:
- Design of your Quality System
- Strategies to cost effectively implement your Quality System
- Regulatory compliance for US, Canada, and Europe
- Technical File for CE Mark
- Device Master Records (DMR) for cGMP
- Writing procedures and instructions
- Validation Management
- ISO standards for biocompatibility, packaging, sterilization, shipping/distribution and other related standards
- Internal audits
- Preparation for a certification audit
For more information please e-mail us at: info@primedENDO.com
We are ready to discuss and serve your Quality needs