Mobile Medical Applications
Mobile medical applications (apps) should be developed following the same process as medical devices, according to the responsible authorities in Europe and the USA. There are many new requirements and specifics manufacturers have to consider. In order to meet the regulatory requirements and develop a successful market strategy, manufacturers need employees with additional qualifications.
We support manufacturers of mobile medical apps as medical devices and in-vitro diagnostics to ensure successful certification or approval. Use our experience and expertise to develop your product idea into a safe and successful app and prepare your employees for this new challenge.
Health Software
We are currently working on the IEC 82304 standard in the working group IEC 62A/ISO 215 JWG7. This standard is intended to fill the gap for “software validation” of stand-alone software and “health software” (defined as “software intended to be used specifically for maintaining or improving health of individuals, or the delivery of care”). Health software can either be classified as a medical device or a non-medical device. In the future, smart phone apps will become health software if they address health, fitness or nutrition. By working on this standard, NSF International can be the first to provide you with important information on software validation, stand-alone and health software and to assist you in development and approval.