Pat Baird, Philips
An AI Medical Device Global Status Update (ISO, IMDRF, Legislation)
Natascha Cuper, Kiwa Dare Services
Common Findings in SaMD Applications and Notified Body Expectations
Jouke Waleson, easee
What's so hard about building Medical Devices for consumers?
Ivo Flipse, Zimmer Biomet
Software Requirements Management
Dr. Anja Kassner, RoX Health
Medical Device Software and IVDR
Dr. Anja Kassner has a history in design and development as well as regulatory affairs of medical devices of different risk classes including recent hands-on experience in successful implementation of MDR requirements for manufacturer of standalone software devices. Currently, she is a team member of RoX Health GmbH and works with selected digital health start-up companies in regulatory compliance projects.
RoX Health GmbH, based in Berlin, is a company builder and accelerator in the field of digital health solutions and a subsidiary of the Roche Deutschland Holding AG. RoX Health focuses on the German healthcare market and provides founders and start-ups with its expertise in the healthcare sector with the aim of ensuring that their solutions are reimbursed by health insurance companies within the framework of the Digital Health Care Act (DVG).
Dr. Oliver Eidel, OpenRegulatory
Agile Development of Medical Devices
Currently, regulatory-compliant software development causes major headaches. Initially, software is developed and code is written. But then, everyone goes crazy, because now they have to create documentation! This sounds a lot like waterfall development, but it's actually much, much worse.
Other fields have made much progress when it comes to management of software projects. You know, all that agile stuff. But can software as a medical device be developed in an agile way? And if so, how would an implementation look like? I'll talk about lessons learned from my consulting experience and which tools to use.
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.
Dr. Johannes Tanne, dentalXrai
Using git for QMS Document Control
Git can be used for the documentation process for medical device manufacturers, especially medical software manufacturers. The presentation will focus on the possibilities of using the version management tool to enable easy traceability and structured document control. As it is already used in the best practice of software development and is common standard in a good software development process.
The documentation not only enables the creation of markdown files, but also helps the user to easily version manage individual documents. This includes documentation from QM master documents, QM records to essential technical documentation records so that documents such as software architecture can be easily kept up to date by developer staff and are auditable for certification audits.
It will be shown how documentation can be realized from creation, review of documents and records to release.
Leon Doorn, Aidence
Risk Management in Decision Support Systems
Ben Meier, curalie
Internal Audit in a Nutshell
Internal Audits are useful as they can reveal your organization's gaps in fulfilling QMS requirements before external auditors notice them.
Since my start as internal auditor for our QMS, I gained some useful learnings. I want to share some best pactices on arriving at "good findings", improving your organization and making every auditor's life easier.
Astrid Ottosen, Radiobotics
Supplier Evaluation of Medical Annotators for AI SaMD
As a SaMD-manufacturer that develops machine learning based devices, we are heavily reliant on training data including training labels, i.e. image annotations of high quality in order to ensure a good and reliable performance of the medical device in the end.
As we use suppliers for the task of annotating the medical images, this puts weight on the supplier and purchasing process. How do we make sure that the image annotations are of sufficiently high quality?
Astrid Ottosen graduated from the Technical University of Denmark in 2016 with a master’s degree in biomedical engineering. Astrid gained experience within the field of quality assurance and regulatory affairs for SaMD as a Product Quality Engineer at 3Shape, before joining Radiobotics as the 7th employee.
At Radiobotics, Astrid is a leading figure within RA/QA and played a big part in the establishment of Radiobotics’ QMS and achieving ISO 13485 and MDR certification of it.
