Remote audits, where all or part of the process is conducted without an auditor present at a manufacturer’s facility, are becoming more common during this period of travel and distancing restrictions. Here are some expert tips on the process.
The EU’s lack of acceptance of remote audits for MDR and IVDR certifications is causing a new backlog in implementation of the regulations, Market Pathways reports. Despite this, remote audits are happening more frequently in the context of COVID-19 restrictions, either for EU surveillance or recertification audits, or under other global authorities or applications. Here are some key expert tips and considerations for device firm’s that may be facing a remote audit.