QUALITY MANAGEMENT SYSTEM

Medical Device Quality Management System as per ISO 13485, MDSAP and 21 CFR 820 for Small, Medium & Large Businesses organizations

EUROPECERT specializes in helping any organization become ISO 13485 compliant inorder to achieve medical device CE Marking or ISO 13485 Certification.

ISO 13485:2016 is an internationally recognized standard for Quality Management for the Medical Device Industry designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world.

We have a very good track record of working exclusively with medical device companies planning for CE Marking across the globe. Our services are structured such a way idel for large , medium and small companies.

Frequently Asked Questions

EUROPECERT can issue ISO 13485 certificate?

No – Only Certification Bodies/Registrars are approved to audit and certify your company to the ISO 13485 standard.
How much time does it take to accomplish ISO 13485 certificate if we don’t have any system set up?

Implementation usually takes 12 weeks for businesses with over 30 employees. Bigger companies with over 50 workers and more number of products and complex manufacturing process will take more time. This also depends on the Certification Body you slected.
When will ISO 13485:2016 be required?

March 1, 2019, is the close of the transition interval for upgrading certificates into the new edition. Producers seeking ISO 13485 certificate for your first time ought to implement procedures and systems which comply with new variant requirements. Find out more about ISO 13485:2016.
Key benefits of ISO 13485

Meet regulatory requirements and Demonstrate that medical devices are produced safely. Increase device sales by accessing more markets.

EN ISO 13485:2016 is harmonized with MDD & MDR, so ISO 13485 implementation is mandatory for CE Marking of medical devices
Benefits of working with EUROPECERT ISO Consultancy
- A network of Overseas Technical and Outsourcing Partners in USA, Middle East and India
- Industry Experienced Consulting Team and Lead Auditors
- Defined & Agreed Project Timescales
- Fixed Cost & Competitive Quotations
- Online Documentation
How to initiate and complete the (EN)ISO 13485:2016 certification process?
The certification process is in three simple steps:
- Appoint EUROPECERT as your Consultant
- Complete the EN ISO 13485:2016 Implementation
- Application for certification to a Certification Body
- Team Training
- Internal Audit
- Initial Certification Audit (Stage 1)
Stage 1 – Documentation Review and readiness audit involves the following:
- Confirm that the quality manual conforms to the requirements of the ISO 13485:2016
- Confirm the scope of ISO 13485 certification including any justifiable exclusions
- Check Leagal ststus of the company
- The report that identifies any non-compliance or potential for non-compliance and
- Agree on a corrective action plan if required.
- Stage 2 date .
Stage 2 – Audit quality management system fully conforms to the requirements of EN ISO 13485:2016 in practice and involves the following:
- Undertake sample audits of the processes and activities defined in the scope of the assessment
- Document how the system complies with the standard
- Report any non-compliances or observations
- Produce an audit programme and confirm a month and year for the first surveillance visit