ABSTRACT

From the proof-of-concept to the commercialization phases, developing a one-of-a-kind healthcare product (medical device) is an expensive and time-consuming endeavor. It will take several years of study and development. Product development processes should be carried out in compliance with appropriate regulatory requirements to save time and money when bringing items to market. These specifications can assist you in staying current with your development efforts and producing a product that fulfills the regulatory standards of your target jurisdiction(s), i.e., a high-quality product that is harmless and actual for its proposed application. Despite fact that information on regulatory requirements for healthcare product development is generally available (e.g., law, guidance documents, international standards), navigating the regulatory system is difficult, especially when dealing with different nations. To help entrepreneurs who are developing healthcare products. The major goal is to improve regulatory understanding of product development and assure regulatory compliance. It could serve as a starting point for the development of your product. The book, rather than a compendium of regulations, covers the key concepts and principles in regulatory affairs. Keywords: Medical Devices, Proof-of-Concept, Regulatory Compliance, Premarket Approval (PMA), Post-Market Surveillance
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9578.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9578