Obtaining regulatory approval to market a medical device is a pre-requisite for most medical devices. Our team of regulatory experts have vast experience in:
- Preparing, submitting and obtaining approval of regulatory files for CE approval in Europe across all device classifications.
- Preparing, submitting and obtaining approval/clearance for US Premarket Approvals (PMAs) and Premarket Notifications 510(k)s.
- Obtaining regulatory approvals for all classes of medical devices in many geographies; Canada, Australia, Brazil, Japan, China and many more across Asia and the Middle East.
- Interpretation of regulations and guidance documents and how to comply with your technical documentation.
- Device labelling requirements and how to comply with them.
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›