Regulatory Affairs
Regulatory Affairs
The field of regulatory affairs "Regulatory Affairs" deals with everything concerning legal or normative requirements for placing medical devices on the market. From dealing with harmonized standards, to conformity assessment and post-market surveillance, RA experts are the point of contact for the requirements placed on these processes and activities by the relevant regulations for economic operators.
In Europe, these requirements are described in the MDR and IVDR, respectively.
The following pages describe how a device can be put on a wide variety of different markets worldwide. Often, a simple registration or confirmation of approval in the home market is sufficient. However, it can also be complicated; for example in China, the hurdles are particularly high. Additionally, in many African countries, a local contact is essential.
We will help you keep track of the different approval restrictions. Our experts know how to bring your product to market - whether in Europe, Asia or America.
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Full service for the reporting of trends in accordance with Art. 88 of the MDR. Learn more about TrendReport.
Regulatory Affairs
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News
Herausforderungen eines Verifikationsingenieurs im Arbeitsalltag
An inside look at the duties, challenges, and responsibilities of a verification engineer – from test planning to quality assurance in day-to-day work.
Health-Software: Medical SPICE® (VDI 5702-Sheet 1:2026)
Medical SPICE® 2.0 explained: How to optimize Healthcare Software Processes according to VDI 5702 (2026) and comply with IEC 62304, ISO 14971, and IEC 81001-5-1.Strategic and regulatory aspects for combination products
Learn how combination products are correctly submitted to the Notified Body Opinion in accordance with regulations – from PMOA assessment to MDR-compliant documentation.Sterilization by gamma irradiation
Alles zur Gammabestrahlung Sterilisation mit Cobalt-60: Ablauf, Vorteile, Anwendungen, Validierung nach ISO 11137 und Einsatz in Medizin, Pharma & Lebensmittel.
