In order to gain market approval, you need successful regulatory submissions that abide by all the unique and complex requirements. At BlueBridge Technologies, our experts have decades of combined experience in and knowledge of the regulatory and stipulation process undertaken to address all regulatory strategies for Software as a Medical Device (SaMD). We can help you with classification, determining the correct device classification and the applicable regulatory pathway to demonstrate compliance to and compilation of the technical file. Best of all, we can do it quickly, accurately and cost-effectively.
Getting You Through Medical Device Regulation
Navigating The Winds of Change
There has been a big shift in the EU’s medical device regulatory framework. The new regulation requires that medical devices be governed in all member states by a law at the EU level. This is instead of the previous EU directives adopted in each member state’s local law. Companies that have not previously been governed by Medical Device Directive (MDD) 93/42/EEC (general medical devices) are now required to comply with the requirements of the new MDR. This represents a significant challenge, as devices previously on the market for several years risk losing market access under the MDR. In the US, the emergence of a significant change of approach has been outlined by the FDA as enshrined in the Pre-Certification program. BlueBridge Technologies will be classified as a level 1 provider from April 2021.
Why Companies Choose BlueBridge Technologies
We can help you navigate the hurdle of the MDR so that you can successfully retain your vital market access to the EU. We can apply the new Unique Device Identification (UDI) mandate intended to facilitate the traceability of all medical devices sold in Europe, to your medical devices and Software as a Medical Device (SaMD). What’s more, we can help you proactively collect PMS data through a combination of questionnaires and analytics built into mobile SaMD applications and analyse the data to help you identify patterns of behaviour.