Collaboration & MDR - Split Tasks, Joined Documentation

Collaboration in the development of a medical device has always been a challenge. The Medical Device Regulation has further increased the requirements for documentation and management of suppliers.

Roles and responsibilities have been redefined, requirements for quality management have been extended, so that well established procedures and workflows are no longer applicable. In addition, there is an increasing desire for agility and flexibility in development - both for software and hardware.

In this presentation you will learn how collaboration and externalization of development can still work and what you should pay attention to. Based on a real product implementation, the pitfalls are shown and possible solutions are presented. You will also learn which tools you can use to support agility in a project and where it reaches agile approach hat its limits.



Was lernen die Zuhörer in dem Vortrag:

  • Collaboration under MDR with focus on roles & responsibilities.
  • Insights into an actual product development including hardware, software and disposables.
  • Schlüsselwörter: MDR, Collaboration, Development


Miriam Schulze, BAYOONET AG

Miriam Schulze studied computer science in Dresden and has been active in the field of medical technology for more than 10 years with focus on risk management and software development.

As Director Medical Engineering at BAYOOMED, she specializes in the standard-compliant development of safety-critical medical software and mobile medical apps in accordance with IEC 62304.

In recent years, Miriam Schulze has been involved in numerous projects as a product owner in the fields of diabetes care, dentistry, women's health, inhalation and ultrasound. She and her team support medtech startups, pharma corporations and medical device manufactures at every stage of the product lifecycle: from specification and consulting to development to CE marking & FDA approval.

Key Facts

Themengebiet: Medizinprodukteverordnung (MDR)

Anspruch: Einsteiger

Schlüsselwörer: MDR, Collaboration, Development

Datum und Uhrzeit: 19. Oktober 2021, 18:15 bis 19:00

Raum: Rom

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