In accordance with ISO 13485:2016 clause 8.2.4 and 21CFR820.22, a Medical Device Manufacturer’s Quality Management System must be audited in accordance with a documented procedure which must be completed impartially by competent personnel.
To help our clients remain compliant, here at Advena we offer a service whereby we can perform an internal audit via desktop to allow an impartial audit of your system.
The benefits of impartiality are not just for continued compliance, but this also brings best practice solutions to your company, dodges intracompany politics and helps avoid the ‘we’ve always done it this way’ mentality.
Audits will evaluate the QMS and regulatory documentation and assess the level of compliance, identifying any opportunities for improvement, observations or nonconformities.
After completion of the audit, we will provide a full written report which can be used as a guide to upgrade the QMS, or alternatively, Advena can upgrade the QMS for an agreed fee.
For more information, please contact us.
