Solid experience in QMS and product registration of medical devices
Our team of engineers combine technical knowledge in the medical field with a strong expertise in Quality Assurance and Regulatory Affairs, ranging from class I devices over sterile devices to patient-specific (custom-made) surgical instruments, implants, and various stand-alone software applications
Specifically, our expertise covers
ISO 13485: Set up ISO13485-certified and FDA cGMP compliant QMS from scratch
Define and execute regulatory strategies for EU and US, incl. FDA interaction (QSub), 510(k), De Novo, CE certification
Support in the development process of medical devices to increase market clearance success
Here's how we've helped others
"Thanks to the professional regulatory team for boosting US access of Customize."
OrthoGrow Advisory offers dedicated and specialized consultancy services in sales, quality and regulatory and general business aspects for medical device manufacturers. OrthoGrow analyzes, advises, plans, co-implements and manages orthopedic business growth through market expansion both strategically and tactically.