The definition of product use-cases, functionality, and expected customer benefits all have major regulatory implications to project costs and schedules. Our team continuously monitors relevant medical device guidance from regulators in the USA, EU, and China.
We have assisted clients in attaining ISO 13485 certification, a CE Mark for a software medical device, NMPA approval for a software medical device in China, and supported submission of 510(k) applications to the FDA. We help clients balance AI technology possibilities with regulatory realities.
FDA Quality System Regulation
The U.S. Code of Federal Regulations (CRF) defines the quality system requirements for medical devices. Regulations are subject to change based on new laws and the ongoing regulatory process. To get the most current version, visit the Electronic Code of Federal Regulations, select Title 21, then select the range beginning with 800.
FDA Software Pre-Certification Program
The US Food & Drug Administration Digital Health Software Pre-Certification (Pre-Cert) Pilot Program will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices.
Quality System Regulations for medical software developers are listed under the provision of Subpart C-Design Controls (820.30). Compliance with Design Controls is a pre-condition for submitting applications for FDA clearance or approval. These controls are specified in the regulation, but the processes used to comply with them can be tailored to each device manufacturer.
International Medical Device Regulators Forum
The International Medical Device Regulators Forum (IMRDF) is a voluntary group of medical device regulators from around the world that discuss future directions in medical device regulatory harmonization. In October 2015, the IMRDF published Software as a Medical Device (SaMD): Application of Quality Management System that defines SaMD lifecycle support, realization, and use processes.
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