There is a substantial increase of regulatory requirements in biomedical engineering in recent years. To continue to meet these requirements a lot of documents have to be created and existing organizational processes have to be optimized. For these tasks quite often there are not enough human resources available and it is not planned to fill these necessary positions, therefore it is suggested to use the existing knowledge of professional service providers.
Services for Medical Devices
While working for a global Medical Device Company I could gain a lot of experiences in the fields of manufacturing and final cleaning of Implants and Instruments, biocompatibility, supplier management, with a special expertise in audit preparation and execution for above listed technical issues. For this reason I can provide this services to Medical Device Companies and their Suppliers:
- Management of Quality Projects
- Assistance for cleanliness, sterility and biocompatibility investigations for medical devices
- Support and consulting services for supplier qualification
Many Medical Device Companies are global players, for this reason it is necessary to find international solutions and to work in global teams. By having the global project lead with teams in different continents I could apply my international project skills as well in the Medical Device business.
Regulatory Requirements
To provide more safety for the use of medical devices the regulatory framework was adapted for this business. The quality requirements for the products will be increased to reduce the risks for the patients.
The implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) is the newest and biggest change, this regulation will replace the existing Medical Devices Direktive (MDD) Council Directive 93/42/EEC (1993) within a transition period of some years.
Some other important requirements and guidelines for the medical devices are listed for example in the standards below:
- EN ISO 13485 - Medical devices. Quality management systems
- 21CFR Part 820 - Quality System Regulation
- EN ISO 10993 - Biological evaluation of medical devices
- EN ISO 14644 - Cleanrooms and associated controlled environments
- EN ISO 11737 - Sterilization of medical devices
- AAMI TIR17 - Compatibility of Materials Subject to Sterilization
- EN ISO 14971 - Application of risk management to medical devices