Remote Medical Device Audits

As a society we prefer to conduct business in person. But some situations (example: budget limitations, time constraints, COVID-19 pandemic) require us to do more work remotely. Audits are no exception and Oriel STAT A MATRIX is fully ready to keep your regulatory compliance efforts on track.

We can perform a variety of audits of your facilities anywhere in the world. Our auditing team is based throughout the US, Europe and Asia, so international time zones are not an issue for us.  These audits can be broad or granular, and fully customized to your specific needs.

And yes, remote audits are valid! ISO 19011:2018 (the standard for how to audit) allows fully remote audits to be conducted and this includes tasks normally conducted on-site including auditee interviews and observations of work performed.

Here are some examples of the types audits we can conduct for you remotely:

• EU MDR and EU IVDR readiness assessments
• FDA QSR compliance
• ISO 13485 and ISO 9001 internal audits
• MDSAP audits
• Supplier audits
• And much more

Same experienced auditors. Same in-depth rigor.

If you are looking for a “good enough for now” audit done remotely, you’re looking in the wrong place. Every Oriel STAT A MATRIX virtual audit is conducted by the same highly skilled auditors with the same thoroughness as our on-site audits. Our network of medical device and IVD auditing specialists have a minimum of 15 years of industry experience and an average of 25+ years of audit experience. All are technologically savvy and fluent in US, European and other national regulations.

Remote audits are not well suited for every situation or company. Some areas are difficult to audit remotely, such as inspections of manufacturing processes. But in the majority of cases, remote audits make sense and are an excellent way to keep your compliance efforts on schedule.

If you have an auditing need, we are ready to support you. Feel free to give us a call or contact us to discuss your specific situation.