Expertise
Our services for your demanding markets
Product support
Technical documentation work particularly review and registration preperation. Our risk classes of MDs and IVDDs, e.g. combination products, digital health devices, software as a medical device.
Quality managment
Establishinga tailored and lean QM solution adressing the requirements of ISO 13485, MDR, IVDR, 21 CFR 820, GMP etc. for your specific area of business and needs.
Manufacturing
Innovative solutions in design transfer to production and optimization concepts for small to large scale production.
Market Entry
With our experts network we facilitate and accelerate your market entry particularly in the D-A-CH countries, North American market, Asian pacific region and Brazil.
Product Registrations
Support and performing with you countryspecific registrations including clinical investigation planning and studies, registrations with UKRP, Authorized Representatives in CH and EU.
About
In 2012 after more than 20 years in executive management in the medical device and IVD industry (Schaerer Medical, Tem Innovations, Miracor Medical Systems) Dr. Oliver Kohr founded KOHRconsultants. He is part of an international network
of experts covering the full range of experience needed giving our customers the best support possible in their fields of expertise.
