ISO 13485 Audit for Medical Device Companies

ISO 13485 is a quality standard with a focus on medical devices and compliance with Regulatory requirement in most countries.

ISO 13485 certification is an important milestone for a medical device company.
The certification is granted after passing an initial audit by an accredited external party.
Companies interested in pursuing a CE Mark are advised to combine the ISO 13485 audit with a CE audit, performed by a notified body.

The purpose of this audit is to ensure the Quality Management System is compliant with the regulations.
During the audit, the auditor conducts a thorough review of the company’s current quality and regulatory documentation through a sampling method.
In order to maintain ISO 13485 certification, annual surveillance audits are performed, the scope of which varies to ensure that the entire quality system is covered. A renewal audit is performed every 3 years that covers the entire quality system.
At the end of each audit, the auditor issues a report summarizing the audit findings and any non-conformities found. After receiving the non-conformity report, the company needs to establish and present a Corrective and Preventive Action (CAPA) plan to address and close the non-conformities.

How can we help?

Our team includes Professionals with documented experience and former officials of the Notified Body TÜV SÜD Product Service (TÜV PS) and GxP Quality System auditors help our clients maximize the value of their products by developing innovative and cost-effective solutions, tailored to meet the needs and objectives of each and every client. 

GemarMed’s experts have more than 20 years of experience in establishing and maintaining quality systems according to applicable regulatory requirements.
GemarMed can help clients by preparing for, participating in and serving as management representative in external ISO 13485 audits performed by various notified bodies and standards institutes

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