Nowadays software is everywhere. Almost all active medical devices will contain embedded software. In addition, more and more stand-alone medical software and medical device “apps” are being developed. According to the European Medical Device Directive (MDD, 93/42/EEC) such software should be treated as an active medical device.
However, existing regulations do not always provide clear requirements for the specifics of software. Simply, because at the time these regulations were developed medical software did not exist to such an extent as it does today. This can result in a mismatch between interpretations by the manufacturer versus the expectations of the Authority or Notified Body.
At MDProject we have many years of experience with medical software projects, including auditing and reviewing technical files from a Notified Body perspective. This includes embedded medical software (e.g. in MR scanners, cardiovascular X-Ray systems and ECG systems), stand-alone medical software (e.g. PACS) and SAAS medical software (Software As A Service).
Furthermore, MD Project participates in e.g. the NEN Platform “Software & MDD” in order to stay on top of new regulatory and standards developments.
We can support you in various phases of software development, e.g.:
Classification of medical device software
Set up of regulatory approval strategy and action plan
Setting up of a software development process based on EN 62304 and / or EN ISO 13485
Participating in risk management and / or usability sessions
Writing compliance reports to EN 62304
Participating in design review sessions
Auditing your software development process against EN 62304 and / or EN ISO 13485
Setting up of a technical file for regulatory compliance based on STED format