Audits are a fact of life for a medical device or IVD company and passing them is a basic requirement. They may be unannounced, or at best inconvenient, they drain resource and increase stress in the organisation. As your business expands, this burden increases, including Notified Body audits for CE certification or ISO 13485, Approved Body audits for UKCA, US FDA Inspections, MDSAP programme and others.
We have a range of services to support you in successfully navigating the audit schedule, reducing the impact on your business progress. These include:
Contact us to explore a smoother path through audits and inspections.
With the sharp rise in home working and in outsourcing critical functions, many medical device manufacturers and distributors are choosing to forego traditional business premises and register their businesses using a virtual office, at their accountant’s premises or even their home addresses. The registered address will need to be used on device labelling and will be where regulatory body audits and inspections will take place. These locations are often unsuitable for such needs – for example hosting 2 or 3 auditors for a number of days and even a virtual office with a bookable meeting room would be inadequate in the event of an unannounced audit.
At Insight Regulatory, we have spacious and private offices where we can provide an office environment with excellent transport links, specifically suited to medical device organisations. With fully-equipped separate meeting rooms able to host up to 12 audit participants and qualified and experienced consultancy staff always on hand whenever an auditor arrives, our virtual office service allows you flexibility to attend an unannounced audit or the ability to participate in the audit remotely, in addition to the usual virtual office services. Please contact us for more details.
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