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Folio Consulting Group, LLC

Your Guide For Navigating the Medical Device Industry

Services FCG Provides:

US Regulatory Strategies

EU Regulatory Strategies

510(k) Notifications

PMA Applications

IDE Submissions

HDE/HUD Submissions

Breakthrough Device Designation Requests

MDR Technical Documentation

FDA Pre-Submissions

FDA Submission Issue Requests

FDA Registration and Listing

FDA Small Business Designation Requests

Performance Testing Strategy

Clinical Study Strategy

Compliance is difficult.
Let us help you navigate the medical device industry.

Folio Consulting Group, LLC offers expert Regulatory Affairs and Quality consulting services for medical device companies. We partner with our clients from start to finish, to translate business objectives into executable regulatory strategies. Navigating the Medical Device industry is complicated. Let us help you identify and tackle the barriers to compliance and premarket clearance [510(k)], approval (PMA) or CE Mark.

Regulations, standards, and requirements are constantly changing. 

Eliminate your compliance questions and create a regulatory strategy to mitigate risks, based on your business and marketing needs.  

Clear out the confusion around US and EU regulations and align your team on how to obtain FDA clearance, approval or CE Mark.
Regulatory Affairs

Expert guidance on all of your regulatory questions and deliverables.

Quality Assurance

Achieve compliance with 21 CFR 820 Quality System Regulation and ISO 13485 Quality Management Systems.

Project Management

Complete your regulatory and quality projects on time and on budget. 

We have helped countless businesses navigate the regulations.

From preparing US Regulatory Strategies to navigating EU MDR requirements, we help medical device businesses understand complex regulations. We perform gap assessments on existing design control documentation and put together plans to ensure  technical documentation will be submission ready. We create quality management systems from scratch and review existing QMS procedures to ensure compliance. Folio Consulting Group manages regulatory projects to ensure on time completion, every time. 

Eliminate your regulatory questions and build a thorough compliance strategy.


We'll discuss your medical device and current regulatory and quality challenges to confirm FCG can provide the perfect solution. 



Based on our call FCG will put together a compliant and efficient regulatory strategy and project plan to help you achieve your regulatory goals.



FCG will work with your team to execute the regulatory strategy in the most effective way that works for your team. Need us to do all the work - we are here. Want your team to do the heavy lifting - we will be your guide.

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CPR Therapeutics Inc. is developing the first advanced technology automated CPR system, one that integrates multiple innovations into a single device that can be easily applied under emergency conditions. We have worked with Lindsey to develop our regulatory strategy. She has a particular expertise in our space, and we have been impressed by the breath of her knowledge and the quality of her regulatory guidance.  We would recommend her without reservation to any company seeking regulatory support.

Norman A. Paradis, MD - President/Founder/CEO


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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