Regulatory Affairs & Quality Assurance Consulting

Navigating Global Regulatory Pathways. Delivering Quality Excellence.

We support medical device manufacturers in navigating regulatory requirements, improving quality systems, and achieving successful audit outcomes.

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How we help

Strategic regulatory and compliance planning
Global submissions and market access support
Quality management system development and remediation
Audit readiness, CAPA, and regulatory response support

15+Years of experience

GlobalRA/QA support

FDA • EU • Canadaand worldwide markets

ISO 13485QMS expertise

About RAQAPathways

Practical regulatory and quality solutions for medical device innovators.

RAQAPathways is a team of experienced Regulatory Affairs and Quality Assurance professionals supporting manufacturers across the medical device lifecycle. Our approach bridges compliance and business success by translating complex requirements into practical, risk-based action plans.

Our experience includes work with manufacturers, Notified Bodies, and consulting organizations, giving our team a broad understanding of regulatory expectations, quality systems, and audit performance.

RA/QA Expertise

End-to-end support across regulatory affairs and quality assurance.

Regulatory Strategy & Compliance

Strategic regulatory and compliance planning
Liaising with regulatory agencies including FDA, Health Canada, PMDA, and others
Regulatory due diligence for business acquisitions
Bridging compliance requirements with business objectives

Global Regulatory Submissions

USA: 510(k), De Novo, PMA
Canada: MDL, MDEL
Japan: PMN, PMC, PMDA, PMA, FMER
EU, UK, Switzerland, Brazil, Australia, New Zealand: Technical Files
Rest of World: LATAM, MEA, East Asia

Quality Management Systems

QMS development and maintenance under ISO 13485:2016
Document control and quality system processes
MDSAP, 21 CFR Part 820, and Regulation (EU) 2017/745 support
Quality system remediation and continuous improvement

Product Development & Validation

Design controls: input, output, verification, validation, and transfer
Process validation: IQ, OQ, PQ
Risk management under ISO 14971
Usability Engineering Reports (UER)

Clinical & Post-Market

Clinical Evaluation Reports (CER)
Post-Market Clinical Follow-up (PMCF)
Periodic Safety Update Reports (PSUR)
Post-Market Surveillance (PMS)
Regulatory reporting and recall management

Audits, CAPA & Training

EU MDR gap assessments
FDA Form 483 response and remediation
Root cause analysis and CAPA systems
Complaint handling and CAPA processes
MDR and MDSAP audit readiness
Internal and supplier audits
cGMP training and compliance

Global Market Support

Regulatory pathways across major and emerging markets.

USA / FDA Canada / Health Canada EU MDR UK Switzerland Japan / PMDA Brazil / ANVISA Australia / TGA New Zealand LATAM Middle East & Africa East Asia

Contact

Ready to discuss your regulatory or quality challenge?

Connect with our team to discuss submissions, quality systems, audit readiness, remediation, or global market access planning.

info@raqapathways.com