Medical Device Consulting
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.
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.
Mission
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.
Medical Device Consultancy Service
The European Community CE marking requirements for medical devices are covered comprehensively
In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.
What will you learn during this Software Development Life Cycle training class.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes.
T.K.
President, Menicon Korea.
KHB
H.H., Project Leader
Shanghai Kehua Bio-Engineering Co., Ltd
L.L. – Quality Leader Asia Pacific
Biomerieux Shanghai Biotech Co., Ltd
Kobridge Consulting is definitively part of our Worldwide Long-Term RAQA Strategy, particularly concerning Stago’s Asia-Pacific operations. We did succeed in building up tight and efficient interactions with Nicolas around a value-added approach beyond “basic” compliance, and this is “key” when considering an IVD outstanding regulated world…
A.C.
Regulatory Affairs & Quality Assurance Director – Stago
D.D.
International Business Development
Wantai
Definition of UDI from the MDR EU MDR UDI has been introduced and even though it may not be new for those selling medical devices in USA, it is a…
EU MDR clinical evaluation EU MDR clinical evaluation requirements are quite overwhelming. There are a lot of requirements and the strategy to achieve conformity is not always clear. We cover…
EU MDR risk management EU MDR risk management requirements can be implemented with the help of the harmonized standard EN ISO 14971. The manufacturer must ensure risk management activities are…
