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Pragmatic regulatory advice that aligns with your business.

We partner with our clients from start to finish, to translate business objectives into executable regulatory strategies. 

We handle the detailed regulatory review and writing so you can concentrate on your business.

Expert Guidance

Regulatory Affairs

Tablet pc device with connection lines on screen in hands of doctor


Quality Assurance

Reaching a Deal

Practical Solutions

Project Management

Serving Multiple Specialties
Medical Devices

We are medical device regulatory experts. We've worked with cardiovascular, orthopedic, spinal, surgical, medical imaging and other devices.

In-vitro Diagnostics

We have helped countless IVD clients develop their regulatory strategies. 


We've worked with CBER to understand the regulatory requirements for biologics. 

Combination Products

We've supported clients with complex combination products navigate the FDA combination product guidance documents for premarket submissions.

Software as a Medical
Device (SAMD)

Our specialty is medical device software. We intimately understand the FDA and EU requirements for medical device software development and documentation.

Who We Are
Committed to Excellence

At Folio Consulting Group, LLC, we understand that navigating the requirements of the medical device industry is not always easy. We are here to serve as your partner, by translating complex regulations into actionable strategies for your business.

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With a deep understanding of regulatory requirements, we make premarket submissions easy.

Click to schedule a free 30 minute initial consultation to see how we can help craft your regulatory strategy. 

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