Get U.S. FDA Market Clearance For Your Medical Device

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What We Do

Global Medical Innovation Solutions (GMIS) is a boutique Contract Research Organization that focuses on delivering U.S. regulatory solutions for medical technology. Our solutions include both the pre– and post–market phases of your product life-cycle to not only help you receive U.S. market access but also for you to remain in regulatory compliance thereafter. We are located in Munich, Germany, but have a global network of ex-FDA experts that allow us to offer exceptional solutions tailored to meet your specific needs.

Our European clients should be aware that although there are similarities between FDA market authorization and the CE mark, there are also notable differences. Generally, the CE mark relies more on self-regulation and a conformity assessment by a Notified Body whereas with the FDA you have to prove safety and effectiveness prior to marketing. And for Class II products, FDA’s QS audit will occur sometime post-clearance. That means you can market and sell your Class II product in the U.S. within 90-days of submitting your pre-market notification (510k) and before your QS audit.

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Solutions

Pre-Market Services:

Regulatory strategy & planning

Submission preparation & management

Regulatory evidence generation

Deficiency assistance

Registration & Listing and U.S. Agent
(Authorized Representative)

U.S. FDA representation

Project management

Access to ex-FDA network & SMEs

Post-Market Services:

Pre-Inspection audit

Warning letter / 483 remediation

Recall assistance

Quality management assistance

Liability protection also available*

Overview of Our Pre-Market Authorization Process

View Our Process

About Us

The core team behind GMIS is comprised of regulatory and scientific experts that are former FDA with over 35 years of combined experience clearing and regulating medical technology within the Agency. Our business model is centered around our client relationships; our approach promotes a win-win partnership where together we are in a better position than we would have been apart. This ethos is always backed by empirical evidence calculated for all business decisions.

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