The COVID-19 situation had undoubtedly created significant challenges for medical device manufacturers and notified bodies. Both, in terms of maintaining the supply chain and performing the necessary audits and assessments. Proactive auditing is key to ensure the various requirements in terms of supplier quality, GxP standards, and technical documentation are met.
With travel restrictions and social distancing measures in place, in some cases, the MDCG allows notified bodies to perform remote audits. The main objective is to ensure the supply of medical devices continues, without jeopardizing the quality of the devices and their manufacturing processes. Notified bodies can leverage technology to perform required audits remotely.
Watch this webinar to learn:
- A notified body perspective towards remote auditing
- TÜV SUD's most recent remote auditing experiences
- How notified bodies and manufacturers can leverage technology
- Veeva’s vision to enable remote auditing in a compliant and easy to use way
- Adjusted ways of working to expect post-COVID-19