Navigate Complex Global Requirements for Medical Device Approval
In the European Union (EU), medical devices are subject to a conformity assessment to ensure essential safety and performance requirements are met. EU member states designate accredited notified bodies to conduct conformity assessments, which usually involve certification of the quality management system (QMS; ISO 13485:2016) and a review of technical documentation, resulting in CE marking your medical device.
Potential obstacles for obtaining approval include a lack of knowledge of the Medical Device Regulation or the In Vitro Diagnostics Regulation (MDR 2017/745 or IVDR 2017/746), lack of capacity, or insufficient regulatory and clinical strategy, any of which may result in costly delays.
At ProPharma Group, our worldwide network of experts has unparalleled experience and knowledge in every aspect of medical device development and approval in the EU, US, and other regions of the world. We can bring your device to market and keep it there, with a focus on efficiency in timelines and cost to help ensure an excellent return on investment.
Medical Device Expertise at Every Step
Our experts are scientists with extensive backgrounds in the development of medical devices, pharmaceuticals, and biotechnology products. From device concept development through CE mark approval, we support companies that have medical devices and in vitro diagnostic medical devices at every stage of the product lifecycle.
Whether you have a stand-alone medical device or a combination product (integrated or not integrated), we can partner with you to bring your product to market and ensure its ongoing success by building and maintaining an effective quality management system (QMS) and managing regulatory affairs throughout the product lifecycle.