The international regulatory authorities have established a well-functioning network. As one example, in Australia, wherever a suspected product incident is suspected, it will be communicated to regulators worldwide within 24-72 hours, with it just being a matter of time before the European regulators announce themselves with a request for detailed product information.
Regulatory cooperation worldwide is also driven by joint audit programs, such as the Medical Device Single Audit Program (MDSAP), a joint undertaking between Canada, USA, Brazil, Australia and Japan. In addition, unannounced audits have now become an established practice. Both at the national and regional levels, e.g. based on the EU MDR or the US FDA Quality System Regulation, as well as at an international level. This means that as an organization, you should be able to expect them at any time - and in so doing be "all-time-compliant". The earlier practice of preparing for an audit / inspection at short notice is no longer valid today. In addition, continuous and consistent further development of the quality management system is significantly more cost-effective than "event-driven emergency action".
The suppliers of medical device manufacturers are also involved in the aforementioned initiatives: During the audit of a medical device manufacturer, their suppliers can also be inspected. Therefore, medical device manufacturers must ensure that their suppliers - even if not certified to medical QMS standards - meet all the requirements of medical device regulations and standards. Supplier management (supplier controls) is therefore an essential element for succeeding in the market.With our specialists at your side, you can be relaxed about your upcoming public authority audits and bring your medical device safely and compliantly to your target markets.