What is a hybrid audit for BSI Medical Devices?
BSI is enthusiastic about the use of hybrid medical device audits. Part of the audit offering remains in-person and onsite, but a significant proportion is now delivered remotely.
The formal definition of BSI medical device hybrid audit:
An audit is partially performed off-site using ICT while at least one auditor qualified under the certification scheme is onsite during a portion of the audit. The audit will be delivered simultaneously with a proportion delivered in person onsite.
As an EU notified body and a UK approved body, we must work with our Authorities in both the NL (IGJ) and the UK (MHRA) to ensure our actions are effective, efficient and legal. The mandatory requirement for onsite audits remains a critical part of the regulatory requirements in the EU and UK. As such, we must return to in-person auditing to ensure your products maintain market access.