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.
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.
1
SCHEDULE AN INITIAL STRATEGY CALL
We'll discuss your medical device and current regulatory and quality challenges to confirm FCG can provide the perfect solution.
2
WE'LL PREPARE A REGULATORY STRATEGY & PROJECT PLAN
Based on our call FCG will put together a compliant and efficient regulatory strategy and project plan to help you achieve your regulatory goals.
3
EXECUTE REGULATORY STRATEGY
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.
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
