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About Us
SMDC Swiss Medical Device Consulting was founded in 2024
The aim of providing independent advice and support to medical device manufacturers in regulatory affirs and quality management.
With over 15 years of experience in development in the medical environment, we not only know the requirements but also pragmatic, lean solutions to ensure rapid market entry.
The main focus is on quality management systems and active medical devices, whereby the following regulations are well known:
In the area of quality management systems
- EN ISO 13485 Quality management systems for medical device manufacturers
- EN ISO 17025 Requirements for the competence of testing and calibration laboratories
From the laboratory environment
- Swiss Low Voltage Ordinance (NIV)
- European Low Voltage Directive 2014/35/EU
- EN IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use
- EN IEC 61326-1 EMC requirements requirements for electrical equipment for measurement, control, and laboratory use
In the area of medical devices
- Swiss Medical Devices Ordinance (MEPV)
- European Medical Device Regulation (EU) 2017/745
- US American QSR (21 CFR 820)
- EN IEC 60601-1 General requirements for basic safety and essential performance
- EN IEC 60601-1-2 EMC for medical devices
- EN IEC 60601-1-6 Usability of medical devices
- EN IEC 60601-1-8 Alarm systems in medical devices
- EN IEC 60601-1-11 Medical devices in home healthcare environment
- EN IEC 60601-1-12 Medical devices in emergency medical service environment
- EN ISO 80601-2-XX series
- EN ISO 14971 Risk management for medical device manufacturers
- EN IEC 62304 Software life cycle for medical devices
- EN IEC 62366-1 Usability of medical devices
By participating in various standards working groups, we are always at the cutting edge of technology and are involved in the following working groups
- SNV NK 195, Conformity assessment (Co-Chair)
- Electrosuisse TK 62, Electrical equipment in medical applications
- Electrosuisse TK 66, Safety requirements for electrical measuring, control and laboratory equipment
- CENELEC TC 62, Medical equipment, software, and systems
- IEC TC 62/SC 62D/JWG 1 - Critical care ventilators
- IEC TC 62/SC 62D/JWG 12 - Home respiratory equipment
- IEC TC 62/SC 62A/PT 62A-1 - Essential Performance fault safety
Your Expert
Beat Keller
After graduating as an engineer from the University of Applied Sciences in Chur, Beat spent several years developing software in the medical field before continuing his training in regulatory affairs and quality management. His many years of experience in regulatory affairs and quality management are your added value with which he helps your company and your projects to enter the market with a pragmatic approach.
Managing Director / Regulatory Expert
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