Regulatory and Quality Solutions for Medical Products
At RESQ Solutions, we help innovators navigate the complex regulatory landscape and build robust quality systems that stand up to scrutiny. Whether you're launching your first device or managing a global portfolio, our team delivers tailored, actionable support that accelerates compliance and strengthens product quality.
Our Expertise
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FDA & EU Submissions
510(k), PMA, De Novo, CE Mark – from strategy to submission
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Quality Management Systems (QMS)
ISO 13485 implementation, audit prep, continuous improvement
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ISO Audit Support & Certification Readiness
Gap assessments, mock audits, and hands-on remediation plans
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Product Evaluation & Regulatory Strategy
Device classification, regulatory pathways, risk analysis
Why RESQ?
Led by John W. Toigo, MS, RAC, a globally recognized expert with over four decades of experience in regulatory, quality, and compliance for critical medical technologies. John was a FDA Lead Reviewer and a subject matter expert in sterilization and biocompatibility, served as a Lead Notified Body Auditor and a Lead MDSAP Auditor, and supported multinational firms and agile startups alike — including during crises like COVID-19 and anthrax response programs.
Our collaborative approach ensures your team stays informed and empowered. We don't just consult — we partner with you to succeed.
Who we serve
MedTech Startups
Established Medical Device Manufacturers
Biotech & Pharma Companies
Contract Manufacturers & CROs
Ready to Move Forward?
Let’s talk about how RESQ Solutions can help streamline your path to compliance and market success.