Medical device manufacturers are obliged to comply with a variety of legislations and regulatory requirements. The Medical Device Directive (MDD) 93/42/EEC regulates the placing on the market of medical devices in Europe. In order to maximize the safety for patients, users and third parties, the Essential Requirements (Annex I) need to be fulfilled.
The compliance with the Essential Requirements are checked from the Technical File. The so called Harmonized Standards support the appropriate preparation of this file. These standards represent a step-by-step instruction for the corresponding application area, e.g.:
- EN ISO 13485 for a quality management system
- EN ISO 14971 for a risk management system
- EN 62366 for usability engineering
- EN 62304 for the software life cycle
- EN 60601-1 for electrical safety
- and many more
We are specialized in application, implementation, interpretation, and auditing of such regulatory requirements.
Our self-developed simulation game “Regulatory Affairs” allows our students to learn the practical application of these theoretical contents.
Publications in our field of regulatory affairs:
- Scholtes M, Behrend A, Buedenbender S, Gross V, Sohrabi K. Didactic Concept to Teach Regulatory Affairs by Means of a Simulation Game. Biomed. Eng.-Biomed. Tech. 2018; 63(s1): S276–S401.
- Scholtes M, Buedenbender S, Behrend A, Sohrabi K, Gross V. Integrating a Usability Engineering Process into a Consisting Risk Management. Current Directions in Biomedical Engineering 2018; 4(1): 645 – 647.
- Scholtes M, Behrend A, Buedenbender S, Gross V, Sohrabi K. Clinical Evaluation of Mobile Medical Apps. Current Directions in Biomedical Engineering 2018; 4(1): 173 – 176.