OrthoGrow expands its Advisory offering with a full range of Quality and Regulatory services. Since full understanding of quality and regulatory implications is a prerequisite for a successful market entry strategy, next to strategic sales advisory, OrthoGrow now has all expertise in-house to offer services in implementation and auditing of Quality Management Systems and product registration according to FDA or EU-MDR regulatory compliance. Furthermore, we can act as your European Authorized Representative through OrthoGrow Distribution, and hereby prepare effective sales startup.
Today, through its EU Authorized Representative OrthoGrow Distribution, Bodycad received product notification confirmation from the Belgian Federal Agency for Medicines and Health Products in Brussels, the legislative capital for the EU, for its personalized unicompartmental knee system. This enables OrthoGrow and Bodycad to commercially launch this truly personalized orthopaedic restoration within the EU, in accordance with current EU Medical Device Directive for custom devices. Bodycad announced FDA 510k clearance for its personalized unicompartmental knee system earlier this year.
Learn more about the personalized knee at the Bodycad product pages.
OrthoGrow Distribution is founded as part of the OrthoGrow group, advisors to the medical device industry, and specializes in (master) distribution and authorized representative services for companies expanding their business in Europe. Through its distribution focused subsidiary, OrthoGrow will be able to extend its abilities to help orthopedic manufacturers grow and accelerate their business in a centralized one-stop-shop principle for local distribution (BeNeLux), master distribution (EU) and associated EU-REP services.