Software as a Medical Device

During this webinar, Prof. Dr. Christian Johner, Johner Institute and Steffen Rehnig, Principal Consultant Software Monetization, Thales DIS, will demonstrate and discuss: - The relevant changes and what they mean for manufacturers of classified software and devices. -Valuable suggestions on how manufacturers can meet the new requirements. - How to avoid compliance problems with software licensing. - How digital transformation can benefit from software licensing. Background FDA and EU-MDR continuously tighten the compliance regulations for medical devices. In particular, the rules recently introduced by the EU MDR could become special challenges for providers of medical software and medical devices with software and could prove to be a major obstacle to future sales development. Therefore, most companies are currently developing and implementing strategies that also mean changes in the supply chain and the systems used for them. Most companies are therefore currently developing and implementing strategies that also mean changes in the supply chain and the systems used for them.