Miriam Schuh
Attorney-at-law
Head of Healthcare
Expertise
- Medical device law and medical law
- eHealth and mHealth: Advising development service providers and manufacturers on the qualification and classification of software as a medical device, in particular with regard to medical apps and advising manufacturers on the application procedure for the DiGA directory
- Artificial intelligence in medical devices
- Contract law along the entire supply chain
- Communication with authorities and litigation
Career
- Studied law in Saarbruecken
- Worked at the Ochanomizu Law Office, Tokyo
- Worked in the legal department of West LB Securities Ltd., Tokyo
- Freelancer in the areas of HR support, HR consulting and employee development
- Attorney at reuschlaw
- Completed course for attorneys specializing in medical law
Current projects (extract)
- Medical devices law: speaking engagements in the public and private sector
- MDR/IVDR: advising international companies on the requirements of European medical devices law
- MDR/IVDR compliance support
- Quality management support: implementation of DIN EN ISO 13485: 2016
Publications (selection)
- Article in 'MPJ – Medizinprodkutejournal', Issue 1/2024, beginning on p. 3: "Die neue Regulierung der Cybersicherheit. NIS-2-RL und Medizinproduktebranche", publisher: Wissenschaftliche Verlagsgesellschaft Stuttgart mbH: Stuttgart
- Article in 'Handelsblatt Inside DIGITAL HEALTH', 16.12.2020: "Unternehmen brauchen einen Bevollmächtigten.", publisher: Handelsblatt GmbH: Duesseldorf
- Article in 'Tagesspiegel Background', 20.05.2020: "Rechtsreform für 'Quasi'-Medizinprodukte.", publisher: Der Tagesspiegel GmbH: Berlin
- Article in 'Quality Engineering', 03.2020, beginning on p. 22: "Das QM bleibt die große Hürde.", publisher: Konradin-Verlag Robert Kohlhammer GmbH: Leinfelden-Echterdingen
- Online-article at 'DocCheck', 19.02.2020: "Digitale Versorgung: Gibt das ein Appy End?", publisher: DocCheck Community GmbH: Cologne
- Online-article at 'computerwoche.de', 17.10.2019: "Das sollten Sie bei Medical Apps beachten.", publisher: IDG Business Media GmbH: Munich
- Article in 'medizin und technik', 03/2019, p. 68: "Das Jahr bis zum Geltungsbeginn der MDR pragmatisch nutzen.", publisher: Konradin-Verlag Robert Kohlhammer GmbH: Leinfelden-Echterdingen
- Interview in 'Qualität und Zuverlässigkeit (QZ)', 09/2018: "Compliance Management in der Kosmetikindustrie.", publisher: Carl Hanser Verlag GmbH & Co. KG: Munich
- Publication in 'Die Qualified Person', 03/2018, beginning on p. 9: "Historie und Haftung der Sachkundigen Person (Qualified Person).", publisher: Concept Heidelberg: Heidelberg
Awards (selection)
- 2020 and 2021: Recognized by Best Lawyers, LLC. as one of the "Best Lawyers® Product Liability Litigation" in Germany
- 2020 and 2021: Award in the area of product liability from the Handelsblatt "Germany’s best lawyers"