Software as a Medical Device (SaMD) is any piece of software that is intended to diagnose or treat diseases or other health conditions. This includes applications that are intended to be used as accessories to pharmaceutical treatments.
To register your app as a medical device or part of a medical device along with a hardware device, various regulatory requirements must be met. Our experts can help you go through the process.
Quality management with ISO 13485 & IEC 62304
ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Compliance with ISO 13485 is the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC, and 98/79/EEC must be assessed before the sale is permitted.
Appotype has initiated the ISO 13485 certification process to provide you with the quality required to sell your medical device in the EU and USA.
We code and report according to IEC 62304. IEC 62304 is a standard that specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union and the United States, and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.