MedTech Regulatory Leadership
for Startups

De-Risk Market Clearance Without Overbuilding RA

Trusted by 50+ MedTech Companies

iCAD • ARPA-H • Evido • CenMedEnterprises • BD • Cook Medical • Alsteni Medical • DeepHealth •

Services Tailored for Startups

We streamline FDA pathways, de-risk submissions, and help you reach market faster.

Regulatory Strategy & Submissions

Expert guidance through every FDA step: strategy to submission, minimizing friction, surprises and doubt.

Start your Strategy

Quality Systems Implementation

Build a robust, scalable QMS aligned to ISO 13485 and FDA QSR, without the headache of an overbuilt system.

Build your QMS

Investor Regulatory Due Diligence

Independent FDA pathway assessments, evidence gaps all time-boxed for Investment Comittee decisions.

Get Diligence Plan

Experience You Can Trust

50

Companies Guided

190

Devices Supported

50+

Years of Experience

Featured Resources

Insights, Case Studies and Tools to accerlerate your regulatory journey

Insights

Short, technical breakdowns of FDA pathways, QMS pitfalls, and real‐world reviewer behavior

Written for MedTech founders who don’t have time to read every guidance document.

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Case Studies

Deep dives on how we have guided startups from concept to clearance: what we found in their files, how we reshaped the strategy, and the impact on timeline, and funding conversations.

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Free Start-Up Kit

MedTech Startup Toolkit
A clear starting point for your first FDA strategy. Get a short primer on how FDA really thinks about pathway, evidence, and stage-based checklists to get you to the next step.

WHAT CLIENTS SAY

"Working with ACG was an outstanding experience! They provided clear and concise guidance on regulatory pathways, making complex processes easier to navigate. Their deep expertise and thorough understanding of FDA regulations were evident and gave us great confidence in their recommendations."

- CEO, Diagnostic Startup

WHAT CLIENTS SAY

“Apsis took us to ISO 13485 certification on the first attempt with no findings. They surfaced gaps we didn’t know we had, guided us through fixing them, and then stayed on as fractional QA leadership. The result was a stronger, audit-ready operation that also gave our business development team the confidence to pursue larger, quality-sensitive customers.”

— CEO, Medical Kit Manufacturer

WHAT CLIENTS SAY

“Working with Apsis felt like having a senior RA/QA lead on call. We got clear-cut, no-fluff answers to our most urgent regulatory questions, usually within a day, and each response translated directly into concrete decisions for our team.”

— CEO, MedTech Manufacturer, Distributor

Ready for FDA Clarity?

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See Who We Serve

Apsis Consulting Group

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Contact

Tel. 475-237-7994

54 State Street, STE 804 #8573

Albany, New York 12207

MedTech Regulatory Leadership for Startups

Trusted by 50+ MedTech Companies

Services Tailored for Startups

Regulatory Strategy & Submissions Expert guidance through every FDA step: strategy to submission, minimizing friction, surprises and doubt.

Quality Systems Implementation Build a robust, scalable QMS aligned to ISO 13485 and FDA QSR, without the headache of an overbuilt system.

Investor Regulatory Due Diligence Independent FDA pathway assessments, evidence gaps all time-boxed for Investment Comittee decisions.

Experience You Can Trust

50

190

50+

Featured Resources

Insights, Case Studies and Tools to accerlerate your regulatory journey

Insights

Case Studies

Free Start-Up Kit

MedTech Startup Toolkit A clear starting point for your first FDA strategy. Get a short primer on how FDA really thinks about pathway, evidence, and stage-based checklists to get you to the next step.

MedTech Regulatory Leadership
for Startups

Regulatory Strategy & Submissions

Expert guidance through every FDA step: strategy to submission, minimizing friction, surprises and doubt.

Quality Systems Implementation

Build a robust, scalable QMS aligned to ISO 13485 and FDA QSR, without the headache of an overbuilt system.

Investor Regulatory Due Diligence

Independent FDA pathway assessments, evidence gaps all time-boxed for Investment Comittee decisions.

MedTech Startup Toolkit
A clear starting point for your first FDA strategy. Get a short primer on how FDA really thinks about pathway, evidence, and stage-based checklists to get you to the next step.