Navigating Global Regulatory Pathways with Confidence
We help medical device and life sciences companies build compliant quality systems, prepare regulatory submissions, and access global markets.
Our Services
Our team provides practical regulatory and quality support from product development through commercialization and post-market compliance.
Regulatory Affairs
- FDA 510(k), De Novo, PMA
- Health Canada licensing
- EU MDR / CE Marking
- Global regulatory strategy
Quality Assurance
- ISO 13485 implementation
- MDSAP preparation
- CAPA and remediation
- Design controls and audits
Strategic Support
- Fractional RA/QA leadership
- Supplier audits
- Risk management ISO 14971
- Training and mentoring
Global Regulatory Markets
We support regulatory and quality pathways across key international markets.
FDA
Health Canada
EU MDR
TGA
PMDA
ANVISA
Industries We Serve
Medical Devices
Support for device companies across the product lifecycle.
IVD & Diagnostics
Regulatory and quality guidance for diagnostic technologies.
Digital Health & SaMD
Support for software, connected health, and AI-enabled solutions.
About RAQAPathways
RAQAPathways is a team of Regulatory Affairs and Quality Assurance professionals with more than 15 years of experience supporting manufacturers, Notified Bodies, and consulting organizations. We deliver practical, business-focused solutions that help clients strengthen compliance and move products forward.
Ready to discuss your regulatory or quality needs?
Contact our team to schedule an introductory consultation.
Email: info@raqapathways.com