OpenRegulatory Conference 2021
Martin Witte, TÜV SÜD
Digitalization of Technical Documentation
The medical device industry is among the most innovative industries and is leading in finding technically advanced solutions for improving patient’s life. However, our ecosystem sometimes lacks effective digitalization, especially when it comes to setting up a Technical Documentation smartly. Traditionally Technical Documentations were created as binders filled with paper. This has definitely changed over the past years, today the typical method is a collection of PDFs or one huge PDF provided in a digital folder structure.
This approach can be understood as "Digitization", not "Digitalization". "Digitalization" would result in improved data usage and in a boost of efficiency. Digitalization requires a lot of preparation and investments. Learn about the notified body’s point of view towards digitalization and get inspired about how you can benefit from a smart data structure in your daily work life.
Martin Witte is Senior Director Strategic Business Development for the Medical Health Service business at TÜV SÜD and responsible for strategic topics such as Active Medical Implants, Cardiovascular, Orthopaedic, and Functional Safety/Software.
Prior to his current role, Martin was a Lead Auditor and Product Specialist for high risk devices. Prior to TÜV SÜD Martin worked on the industry side for 6 year as a Regulatory Affairs Manager with BIOTRONIK focusing on heart rhythm management devices and MRI safety of active implantable devices. Martin is a strong supporter of digitalization in the Medtech world.