Ensure ongoing compliance with standard during the pandemic
Medical device manufacturers are providing life-saving equipment to care for patients who have been infected with the coronavirus. But how do you conduct a third-party audit required for market access when most of us must work remotely?
That was the challenge Eurosets, a leading manufacturer of innovative cardiovascular and cardiopulmonary devices, faced. Based in Medolla, Italy, the company’s products include extracorporeal membrane oxygenation (ECMO) systems, now being widely used in intensive care units with patients suffering from severe COVID-19 symptoms.
Eurosets is certified against ISO 13485:2016, Medical Device Directive (MDD) and Medical Device Single Audit Program (MDSAP), which positions the company to market and distribute its products throughout the European Union (EU), as well as in countries participating in the MDSAP.
Maintaining certification requires periodic on-site audits to ensure ongoing compliance with the standard.
With mandatory work from home requirements in place throughout Italy, auditors from TÜV SÜD had to quickly establish a virtual auditing environment to conduct the entire auditing process remotely. They also had to ensure that their auditing process was aligned with the latest requirements from regulatory authorities.
Based on the experience from our colleagues in China, who had to face this challenge earlier this year, the Italian team established a virtual auditing routine including an online platform, with virtual rooms for each auditor. The auditors then scheduled online meetings with key personnel at Eurosets to evaluate required aspects of the company’s management system. Essential documents were hosted in a dedicated shared storage on the platform, giving everyone immediate access to relevant information.
TÜV SÜD’s approach ensured on-schedule completion of the mandatory serveillance activities for Eurosets’ quality management system. This not only allowed the company’s essential production activities to continue seamlessly but also served as a blueprint for other regions' remote auditing activities..
At a time when prompt access to essential medical equipment and devices can be a matter of life and death, TÜV SÜD stands ready to offer innovative service solutions that meet the essential needs of the medical device industry and the vital demand of medical device supplies in the healthcare sector around the world. Find out how TÜV SÜD's Medical and Health Services are working to support customers during the outbreak here.
Safeguarding the well-being of employees and customers