Folio Consulting Group, LLC

Folio Consulting Group is a regulatory affairs and quality systems consulting firm serving medical device manufacturers seeking FDA clearance, approval, or CE Mark. The team specializes in translating complex regulatory requirements into actionable strategies for startups and growth-stage companies navigating US and EU market authorization pathways.

The firm provides regulatory strategy development, submission preparation (510(k), PMA, De Novo, IDE, HDE), EU MDR technical documentation, quality management system implementation, and project management services. Their expertise extends across multiple device types including cardiovascular, orthopedic, surgical, medical imaging devices, in-vitro diagnostics, biologics, combination products, and software as a medical device (SAMD).

Led by a team with engineering and regulatory backgrounds, Folio Consulting Group combines technical understanding with regulatory insight to guide clients through FDA pre-submissions, breakthrough device designations, and quality system compliance with 21 CFR 820 and ISO 13485 standards.

Choose Folio Consulting Group when you need specialized regulatory expertise for complex medical device submissions, particularly for software-based or combination products. Their engineering background enables them to understand technical nuances that impact regulatory strategy, making them valuable for companies with innovative or technically complex devices.

Expect collaborative engagement where they translate business objectives into compliant regulatory pathways. Their approach emphasizes flexibility—they can execute fully or guide internal teams through the regulatory process, adapting to your resource constraints and preferences.

Folio Consulting Group exclusively serves the medical device sector, focusing on regulatory affairs and quality systems for manufacturers across cardiovascular, orthopedic, spinal, surgical, medical imaging, in-vitro diagnostics, biologics, and combination products. Their healthcare focus centers on navigating FDA and EU regulatory pathways including 21 CFR 820, ISO 13485, and MDR compliance.

They specialize in supporting medical device innovators bringing new technologies to market, with particular expertise in software as a medical device (SAMD) and devices requiring clinical study strategies or performance testing protocols.

Early to mid-stage medical device companies preparing for their first FDA submission or EU market entry. Companies developing innovative technologies that require strategic regulatory planning, particularly those with software components, combination products, or devices requiring specialized FDA programs like Breakthrough Device Designation.