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.

Our Compnay

About Our Company

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.

MORE ABOUT OUR COMPANY
Mission

Mission 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.

 

+82(0)263366763info@kobridgeconsulting.com

SERVICES WE PROVIDE

Medical Device Consultancy

Europe
Europe Medical Device Registration

The European Community CE marking requirements for medical devices are covered comprehensively

Medical Device Consulting
ISO 13485 And Main Changes Since 2016

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes.

FDA clearance
How to Get The FDA Clearance?

In order to get FDA clearance for you product, you need to comply with one or more of the following requirements.

Medical Device Consulting
Medical Device Single Audit Program (MDSAP)

MDSAP is one of the (too) few harmonization program among different regulation systems

World Health Organization
WHO Prequalification Of Diagnostics

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.

Audit
Internal Audit

We provide expertise in auditing that can drive change and improvements more effectively.

Canada
Canada Medical Device Registration

How to get Approval for Canada Medical Device Registration? Health Canada reviews medical devices to assess their safety.

Life Cycle Training
Software Development Life Cycle Training

What will you learn during this Software Development Life Cycle training class.

Risk Management
Risk Management Training

What will you learn during this Risk management training ISO 14971 class.

OUR ORGANIZATION

How our Medical Device Consulting service is organized ? Whether we have the competencies internally or not, we always to find the right skills and make sure people are fully qualified and adhere to our values and core beliefs.

Organization

Organization

Here are some examples of testimonials we'd like to share

Some of the feedback we got regarding Medical Device Consulting.
Medical Device Consulting
I would like to recommend the services of Kobridge Co.
Our organization used their services for the registration of our products in South Korea, which was executed successfully.
The key factor for the success of the project was their capability to adapt, communicate throughout the project.
We had to work under tight deadline and budget for the project and Kobridge was as close as can be.

T.K.
President, Menicon Korea.

Medical Device Consulting
I am happy to provide a reference for Kobridge Consulting, a consulting firm I have worked with recently. I’ve known Nicolas Clary the Director of this firm for more than 5 years and find him to be a respectable consultant who runs his firm with integrity and skill. From upgrading my quality system to advising us on the best strategies, Kobridge has always been straightforward and honest. I’m happy to recommend them to anyone seeking advice for quality assurance or regulatory submission.

KHB
H.H., Project Leader
Shanghai Kehua Bio-Engineering Co., Ltd

Medical Device Consulting
It is my pleasure to recommend the consulting services of Kobridge Consulting. During the past, our team has worked directly with Nicolas Clary, CEO of Kobridge Consulting, on several projects. The company offers reliable service and we were pleased with their work. On projects like auditing in particular we realized the added they were able to provide through attention to detail and connections with regulators. We are convinced that their approach of service can lead to great success. Please consider Kobridge Consulting for all your Regulatory/Quality strategy. I recommend them and look forward to working with them again.

L.L. – Quality Leader Asia Pacific
Biomerieux Shanghai Biotech Co., Ltd

Medical Device Consulting
We know Kobridge Consulting since the early beginning by interacting with Nicolas Clary on a regular basis in regard with both QA & RA matters.

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

Medical Device Consulting
For our project, time and immediate result were the main challenges. From that perspective, Kobridge Consulting responded extremely well and we could meet our deadline. We would definitely not hesitate to recommend the services of Kobridge Consulting.

D.D.
International Business Development
Wantai

RECENT NEWS

Jan132022
MDCG

MDCG

CE MarkingLeave a comment

Everything You Need To Know About Medical Device Coordination Group (MDCG) The Medical Device Coordination Group (MDCG) is a regulatory body of health and industry experts with the goal to…

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