Auditing services for medical devices industry

We develop effective yearly audit plans that turn auditing into an effective tool, not just a mandatory requirement.

Internal audits

Internal audits are part of the continuous improvement of the QMS and are mandatory. They identify gaps and the effectiveness of your quality management system. Internal audits give you confidence that regulatory requirements are accurately implemented in your processes.

We view internal audits as ways to improve rather than solely for compliancy to get the most of out of your QMS.

full ISO 13485 QMS audit
partial ISO 13485 audit, such as only management responsibility
full or partial ISO 9001 audit
full or partial ISO 13485+9001 audit
full or partial ISO 13485 audit + MDR/IVDR
full or partial ISO 13485 audit with emphasis on applicable standards such as IEC 62304 or IEC 62366.

Supplier audits

The quality of the materials or components you use in your medical device are a prerequisite for the quality of your product. Suppliers need a control method to ensure their operations are at the desired level.

A supplier audit is the most effective way to ensure that your suppliers comply with applicable standards and regulations, as well as your needs. We can audit your candidate suppliers before you approve it and take care of the follow-up audits.

How can we help?

An auditor provides new insights to your quality management system, we can cover: ISO 13485:2016

ISO 9001:2015
MDR 2017/745
IVDR 2017/746
FDA QSR
MDSAP
Additional weightings for standards

Contact us for more information

Quality Management System ISO 13485

Setting up quality management systems (QMS) for medical device manufacturers.

US FDA 21 CFR Title 820 (QSR)

We know quality systems, including the USA Food and Drug Administration Quality System Regulation, QSR, 21 CFR Title 820.

QMS Improvement and Gap Analysis

Improvement of medical device manufacturer’s quality management system (QMS) and GAP analysis.

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Auditing services