Expertise and Impartiality: the Key to Successful Audits

Audit

Benefit from the expertise to conduct your audits in compliance with ISO 13485 and 21 CFR Part 820 requirements.

By complementing your team with external skills, the objectivity and impartiality of the evaluations are guaranteed.

You can also optimize your audit plan, even with a large number of suppliers and service providers.

Internal Audits

The various processus of your quality management system
are audited to ensure their compliance
and continuous improvement.

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Supplier and Service Provider Audits

We provide support for the selection, qualification, and monitoring of your suppliers
of raw materials, components, finished products, as well as your service providers,
such as sterilization subcontractors and testing laboratories.
These external audits can be adjusted according to the specifications of your contracts.

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Identification of Areas for Improvement

A personalized intervention helps identify areas for improvement
in your quality management system or its compliance
with new regulations, such as MDR 2017/745.

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Certification Audit Preparation

With extensive experience in audits (ISO 13485, CE marking 2017/745, MDSAP) and inspections (FDA, ANVISA), we offer tailored support for every stage of certification audits and inspections.

Comprehensive preparation, assistance during audits, and thorough follow-up of any non-conformities are provided to ensure your certification.

 

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Due Diligence Process

 

As part of your acquisition or integration operations, we assist in evaluating files regarding regulatory, quality, design, and production control aspects.
Our expertise ensures the efficient and smooth management of your audits, allowing you to focus your resources on strategic priorities while ensuring optimal quality and full compliance.

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Contact us

We are here to help you

+33 6 78 48 56 29

contact@medwayconsult.fr