Your Regulatory GPS

Global Regulatory Solutions, Start to Finish.
Winning Medical Device Approval for 30+ Years

Powering Startup Nation Success Stories
Certified Vendor for Top NASDAQ Medical Device Manufacturers
The Go-To Experts for Digital Health Devices
Trusted by VCs and Serial Entrepreneurs
Recognized and Endorsed by Academia
Trusted by

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Testimonials

Together with Professor Shlomo Ben-Haim and his team, we turned the medical device approval process into a competitive advantage. By integrating regulatory science, medicine, business and technology, the Hobart Group and Physio-Logic have fostered scores of unprecedented approvals and developed a rapid concept-to-market formula for success

Testimonials

Physio-Logic successfully accelerated our 510 (k) clearance. It was very pleasant to work with Physio-Logic, communication was very clear to the point they were very efficient, responsive and on time.

Testimonials

Physio–Logic dedicated team guide and paved the path for Viora’s MDSAP clarification. We look forward to continue our long lasting collaboration with Physio-Logic.

Testimonials

Thank you for a great job with the MDSAP certification. We have benefited from a real professional team. We consider you part of the Venus Concept family, and a very good part.

Testimonials

Our firm went through a pre-approval FDA inspection, our advisor and partner for this journey was Physio-Logic led by Gadi Ginot. Their expertise, dedication and commitment enabled our entry to the prestigious league of companies meeting FDA requirements.

Testimonials

Working with Physio-Logic was a great experience.  We were immediately taken by the team’s depth of experience and expertise.  They became part of our company, and led the regulation and part of the validation programs with incredible attention to details.  The knowledge, Intelligence and persistence support of Physio-Logic enabled the completion of the project to everyone’s great satisfaction.

Gain the insights, advice and tools to achieve your mission-critical priorities

Who We Are

We design and execute winning regulatory strategies, on time and on budget.

Our multidisciplinary team powers start-to-finish solutions, lifting the regulatory burden off your shoulders. Discover our formula.

Discover our formula
Our scorecard
175
FDA Q-Sub/Approval/Clearance
+500
CE Mark & ISO 13485
19
FDA inspections
12
EU MDR Transitions
+300
International Clinical Trials
17
MDSAP Certifications
our Services

Gain the insights, advice and tools to achieve your mission-critical priorities

Digital Health Practice
Medical Device Practice
In-Vitro Diagnostics Practice
Clinical Research &
Usability Practice
COVID-19 Emergency
Authorization

Our Compliance
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