Any go-to-market strategy should demonstrate a full understanding of quality and regulatory implications. Market entry strategy is also based on potential hurdles, considering risk management, device classification, clinical evaluation and overall compliance with national regulatory requirements and current Good Manufacturing Principals. Therefore, OrthoGrow does not only focus on your sales approach to generate growth of your medical device business, but also offers advisory 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.

ISO 13485

OrthoGrow offers QMS compliance services to make sure you are fully compliant with the most recent requirements. Our quality and regulatory experts identifies QMS gaps, prepares for certification, performs internal, pre-certification or supplier audits and offers on-site training in view of ISO 13485:2016 for medical device companies.

To learn more, please contact niels@ortho-grow.com.

FDA

If you plan to expand your business into the United States, OrthoGrow offers FDA cGMP and 510(k) consulting for medical devices. Since the FDA premarket approval processes can be costly and complex, professional advice is key to optimizing your application from the very beginning, choosing the right pathway and providing sufficient information. Our quality and regulatory experts identifies FDA gaps, and prepares for application, performs internal audits and assists in managing contacts with FDA, thinking strategically along with you through the approval process. Furthermore, we can provide training and support to your team when facing an FDA inspection, both during the preparation, the inspection and the closure of potential findings.

To learn more, please contact niels@ortho-grow.com.

EU-MDR

OrthoGrow offers gap identification and internal audits in view of the new EU-MDR impacting medical device companies. Our quality and regulatory experts can support you in the transition from the Medical Devices Directive to EU-MDR, with training, audits and implementation.

To learn more, please contact niels@ortho-grow.com.