The world in which medical device manufacturers are operating is growing with complexity, new challenges and increased risks.  At the same time, there are enormous opportunities to leverage to overcome these challenges thanks to scientific and technological advances in the medical pharmaceutical industries. 

As a regulatory consulting company,  Mtech Group consultants have professional experience and expertise to assist our customers with the best available medical science and practice in the industry.  An extraordinary and talented team of Mtech Group consultants include: 

Dr. Lukas W. Joo, MD (lukas.w.joo@mtech-inc.net)

- Medical/Clinical Application, Biocompatibility, Sterilization, Shelf Life, Risk Management

Dr. Young Wan Kim, MD (younwan.kim@mtech-inc.net)

- Medical/Clinical Application, Medical Device Development, Desing Control

Ms. Sarah Kim, JD (sarah@mtech-inc.net)

- Medical device medicare coding, GUDID, FDA regulations

Mr. Dave Kim, MBA (davekim@mtech-inc.net)

- FDA 510K, HC medical device license, Quality control and audit

 We understand the challenges the medical device manufacturers face globally and we are committed to deliver extraordinary outcomes for our clients and guide them through complex pathways of medical device regulations

What We Do

We provide indiviualized medical device regulatory consulting for medical device manufacturers pertaining to establishment registration, device listing and regulatory clearance of medical devices, and cosmetics  on behalf of our clients. We represent our clients as an official correspondent and US agent in any transactions or communications with the FDA and HC during the medical device application, review and approval process.

 The responsibilities of the U.S. agent include:

• Assisting the FDA in communications with the foreign establishment 
• Responding to the questions concerning the foreign establishment's devices that are imported or offered for importation into the US, and
• Assisting the FDA in scheduling inspections on the foreign establishment.

Contact Us Today!

We prepare all medical device approval documents, such as 510K application, and submit the documents to an appropriate regulatory agency such as FDA and HC on behalf of our clients. 

• Free Initial Medical Device Regulatory Consultation
• Technical Document Translation

Please contact us anytime! We look forward to hearing from you.

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