Medtech

In the definition of the development strategy and the related regulatory roadmap RPN supports capturing all the activities to verify the feasibility of the company’s projects, while taking the client closer to marketing authorization, shortening the time to market.

In the ever-evolving landscape of medical device development, the need for concrete evidence to substantiate clinical performance and safety is the key to accelerating the device’s path to market.

In the early stages, RPN assists in finding the optimal approach to the medical device design phases, product regulatory framing, classification, requirements, and costs by contemplating regulatory objectives to meet the expectations of regulatory authorities.

Whether it’s aligning with (product) standards, verification testing, comprehensive literature reviews, or conducting clinical studies, our collaborative Development Strategy approach guides the client in navigating the complexities of gathering essential evidence.

Our track record spans from partnering with startups to collaborating with industry giants, encompassing devices across the spectrum from Class I to Class III, from substance-based to digital software and apps.

RPN comprehensive support includes:

• Identifying the proper legal framework for borderline products, i.e., products that due to their nature do not clearly belong to a specific field.
• Identifying the specific regulatory requirements to be addressed.
• Seamlessly integrating with risk management activities/plans.
• Establishing a coherent link to clinical claims.
• Validating the necessity for collecting additional clinical data.