Kobridge is a Medical Device Consulting firm specialized in regulatory affairs and quality system. We are specialists of global market submissions, especially for Europe, US, and Canada. Kobridge is helping medical device manufacturers since 2007.
Welcome to Kobridge
Medical Device Consulting
Medical Device Consulting Service – Regulatory Affairs and Quality Assurance.
Medical Device Consulting in today’s world is a necessity due to the increasing complexity and heterogeneity of the medical devices regulations in the world.
Mission
- Always enjoy what we are doing
- Find strategic solutions, embrace all objectives
- Keep learning, all the time
Our Core Technical Competencies for medical device consulting:
- CE Marking
- Canada Approval
- FDA
- MDSAP
- Active and Non Active Devices
- Combination Devices
- Animal Origin Devices
- Sterilization
- Software Validation
- Biocompatibility
- Packaging
Contact us today and get
FREE FIRST CONSULTATION about our Medical Device Consulting services.
SERVICES WE PROVIDE
Medical Device Consultancy
The European Community CE marking requirements for medical devices are covered comprehensively
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes.
In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.
MDSAP is one of the (too) few harmonization program among different regulation systems
If you are looking to expand your market and apply for the WHO prequalification of diagnostics program, you may wonder what are your option and how to proceed.
We provide expertise in auditing that can drive change and improvements more effectively.
How to get Approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.
What will you learn during this Software Development Life Cycle training class.
