The new regulatory requirements increase the complexity for medical technology companies: Following the publication of the Medical Device Regulation (MDR), which comes into force on 26.05.2020, additional requirements imposed by German legislation (Medical Device Adaptation Act (MPAnpG-EU) and Medical Device Implementation Act (MDG) were presented.
Do not consider these challenges as a disadvantage. After all, the requirements for software development in medical technology are now clearer and the necessary steps for action more visible. Our certified experts will support you on this path. Due to the high quality of our software throughout the entire regulated development process, we guarantee the highest level of safety for your patients.
OUR OFFER FOR GUIDANCE AND SUPPORT
We advise and support you in the implementation of the new requirements for software in medical technology. In addition, our experts carry out gap analyses (MDD -> MDR) and work out the need for action in your organization in context-related workshops together with you.
Furthermore, we support you in document creation and reviews. This is where you can start at any time - at the start, during the ongoing process or for review and rework.
WHY ADESSO?
- Our employees are "Certified Professionals for Medical Software" (CPMS)
- We have experience in quality management in a wide range of industries
- We have project experience in the creation of technical files for medical devices
- We are familiar with the programming of validated software products as well as with tool validation in medical technology
- We implement your software requirements pragmatically, solution-oriented and in partnership
- We make it possible for you to promptly accompany and implement your requirements in the field of medical technology
- We are certified according to 9001 and on the way to ISO 13485
- We use Medical SPICE to assess and optimize the processes required by the standards (ISO14971, ISO 13485, IEC 60601-1, IEC 62304, IEC 62366)