IM3 Consulting Group
Applying Science to Regulatory & Compliance
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IM3 is a consulting group catering to the medical device and combination device (device-drug/biologics) industries. We specialize in Regulatory Affairs, Quality & Compliance, Test-Protocol Development, Sterilization & Packaging, and General Design & Technical Services.
Although our staff is diverse in background and experience, all of our partners have advanced technical degrees in either science or engineering, with significant work experience in both start-up and established medical firms. Every member of our group has worked in a lab and has managed R&D and Regulatory professionals, and has an extensive patent portfolio with numerous peer-reviewed publications. Finally, all of our partners have direct experience working with regulators in the US and international markets, including serving as advisors to the FDA.
We have been involved in a wide variety of medical technologies including implantable cardiovascular devices, diagnostics, neurostimulation, endoscopy, ophthalmic implants, remote data-monitoring, hospital & industrial sterilization, cleaning & disinfection of devices, device-biologics combination products, stem cells, orthopedic implants, regenerative medicine, robotics, and surgical instrumentation, among others.
Unlike any other consulting group in the medical device area, we know what it means to work in industry, balance a budget, and meet a timeline. We are pragmatic and speak your language. We are well grounded in science and technology, and approach every project with logic and reason. And we are selective in what projects we work on in order to ensure success.
Contact us today at info@im3consultinggroup.com