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)
- Supporting economic operators in the healthcare sector in the implementation of the regulatory requirements of MDR and IVDR
- Supporting manufacturers of medical devices, including IVDs, in contract management with critical suppliers and distributors, including the negotiation of quality assurance agreements
- Supporting manufacturers of medical devices, including IVDs, in the (re)structuring of vigilance processes, in particular for the efficient implementation of market measures in cooperation with distributors and international regulatory authorities
Latest News
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)
- 2021, 2022, 2023: Recognized by Best Lawyers, LLC. as one of the "Best Lawyers® Product Liability Litigation" in Germany
- 2021, 2022, 2023: Award in the area of product liability from the Handelsblatt "Germany’s best lawyers"