Our Vision
We envision a MedTech landscape where innovative products reach patients without being stalled by regulatory uncertainty. We help startups deliver life-changing technologies faster with an expert regulatory strategy.
Our Story
Apsis Consulting Group began with a single mission: to simplify the regulatory maze for medical device startups. Since our founding, we’ve guided dozens of companies toward faster approvals and successful product launches.
Our Experience
With a combined 50+ years in the medical device sector, our experts have guided 100+ regulatory submissions. We’ve navigated complex clinical trial designs, negotiated with the FDA and advised on market-launch strategies for both early-stage startups and Fortune 500 firms. .
40
CUSTOMERS ADVISED
190+
MEDICAL DEVICES WORKED ON
3
AVAILABLE
CONSULTANTS
50+
YEARS OF MEDICAL DEVICE EXPERIENCE
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Navigating FDA pathways doesn’t have to be a headache. We streamline submissions and manage regulatory hurdles, so you can focus on driving innovation.
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Quality Support
A strong QMS is the backbone of any successful medical device launch. We help you implement FDA-compliant frameworks that reduce risks.
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Resource Augmentation
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Need specialized expertise without the overhead? Our flexible resource augmentation model provides skilled regulatory professionals exactly when you need them—no long-term commitments.
