Mobile medical applications

The development of Mobile medical applications (apps) needs to follow a development process equal to medical software. This is the statement of the responsible European and American authorities. Practice shows that there are many new requirements and particularities for manufacturers to consider. In order to meet the regulatory requirements on the one hand and to develop a successful market strategy on the other, manufacturers need employees with additional qualifications.
During the last few years PROSYSTEM has successfully accompanied many manufacturers of “mobile medical apps“, which were categorized as medical or in-vitro diagnostic devices, during their certification and approval process.
Benefit from our experience and expertise, so that your product idea will become a safe and successful “app”. Additionally, we help to prepare your employees for this new challenge.

Health software

At the moment PROSYSTEM is a member of the workgroup of IEC 62A/ISO 215 JWG7 which is currently working on the IEC 82304 standard. This standard will close the gap “software validation” and additionally covers the topics “standalone software” and “health software”.
“Health software” is defined as follows: “Software intended to be used specifically for maintaining or improving health of individual persons, or the delivery of care.” This means that “health software” may be a medical device but does not have to be one per se.
In the future applications on smartphones will become “health software” if for example their intended use covers health, fitness or nourishment.
PROSYSTEM is able to provide you with insider information on the topics software validation, standalone- and health software due to its workgroup membership and offers to accompany you during the development and the approval of your medical software.