At the beginning of December, we hosted a webinar for Startups as part of the StartSmart CEE acceleration program. The Head of the ISO QMS Unit led the webinar, which shared its knowledge and expertise on the qualification and classification of software as a medical device. The ISO QMS Unit is responsible for all activities related to the preparation, implementation, and enhancement of the Quality Management System and digitalization/validation processes at SciencePharma.
During the webinar session, we discussed key topics related to the requirements and processes for bringing software to the market as a medical device, including:
- Qualification of a medical device according to MDCG 2019-11 and Regulation (EU) 2017/745 (MDR).
- Classification of a medical device based on Regulation (EU) 2017/745 (MDR).
- Software safety classification according to the IEC 62304:2006 standard.
- Classification and what’s next? – The medical device certification process.
We are pleased that we were able to provide insights into these critical topics related to introducing innovative solutions to the medical market. This has been a very valuable experience for us, and it’s genuinely a pleasure to support Startups in such a crucial area. We hope our guidance will help refine and prepare products for market entry.
We are keeping our fingers crossed for all the Startups participating in the StartSmart CEE acceleration program and wish them success in bringing medical devices to the market! More information about the program you can find here.
