Fractional Regulatory & Quality
Regulatory and quality expertise is the most common gap at growing medical device companies. Our fractional R&Q consultants provide senior-level guidance without the cost of full-time headcount.
Talk to a SpecialistRegulatory and quality management are existential functions for medical device companies. Missteps cost years and millions of dollars. Many companies—especially early-stage—need access to senior regulatory and quality expertise but cannot justify or afford full-time headcount.
Our fractional regulatory and quality consultants have managed 510(k), De Novo, and PMA submissions, built QMS programs from scratch, navigated FDA inspections, and achieved CE marking for dozens of device companies.
What Our Regulatory & Quality Experts Provide
- FDA 510(k), De Novo, and PMA preparation and submission
- ISO 13485 QMS design, implementation, and gap assessments
- EU MDR technical documentation and Notified Body submissions
- Design Controls and Design History File development
- FDA inspection and CAPA management
- Post-market surveillance and MDR/MDV reporting
Ready to Engage a Specialist?
Short-term. Virtual. Expert-level. No long-term commitments required.
Contact an Expert