Audit of a medical device manufacturer

Conducting an inspection of a medical device manufacturer by a notified body. The audit can be performed on-site, remotely, or through the recognition of a European certificate.

The primary goal of the audit is to confirm the manufacturer’s compliance with national and international regulations, standards, and other documents governing the quality of medical device production.

The audit may be conducted to obtain conformity certificates, inclusion in the Register of Responsible Persons for placing medical devices on the market, and to authorize the import of their products.

Audits are carried out by accredited notified bodies, with personnel who possess the necessary qualifications and experience according to regulatory requirements and standards. During the audit, the manufacturer’s quality management system and technical documentation for medical devices are examined. The outcome of the audit is the issuance of a conformity certificate for the product or quality management system.

To successfully pass the audit, it is recommended to prepare the quality management system and technical documentation, conduct an internal audit, and involve external experts with relevant experience.