ISO 14971 Risk Management
Complete Risk Management Files — plans, hazard analysis, DFMEA/PFMEA, benefit-risk analysis, and post-market integration. Audit-ready from day one.
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Accepting New Clients — Remote & On-Site Worldwide
Strategic Medical Device
Compliance & Consulting
Accelerate your path to market with audit-ready ISO 14971 risk management, ISO 13485 quality systems, and FDA 510(k) submissions. Start your project as early as tomorrow.
Regulatory Expertise Across
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FDA
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EU MDR
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Health Canada
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SFDA
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MDSAP
What We Do
Comprehensive Regulatory & Quality Solutions
From risk management files to full QMS implementation, we simplify complex regulations into clear, actionable strategies tailored to your device.
ISO 13485 QMS Consulting
Gap assessments, SOP development, internal audits, CAPA management, and full QMS build-outs that satisfy FDA, EU, and MDSAP auditors.
Learn moreFDA 510(k) Submissions
Strategic predicate selection, testing plans, eSTAR preparation, and pre-submission meeting support for successful FDA clearance.
Learn moreEU MDR & CE Marking
MDR transition, GSPR compliance, Clinical Evaluation Reports (CERs), Post-Market Surveillance plans, and Notified Body preparation.
Learn moreSFDA Registration Support
Technical file preparation, GHAD e-submission, device classification, labeling localization, and MDMA renewal strategy for Saudi market access.
Learn moreGap Analysis & Remediation
Legacy device remediation, traceability rebuilding, technical documentation updates, recall prevention, and 483/deficiency response.
Learn more20+
Years Industry Experience
100%
Audit Success Rate
60+
Projects Delivered
Global
Client Reach
Why Regulatory
Assist
Expertise You Can Trust.
Expertise You Can Trust.
Speed You Can Count On.
We don't just advise — we implement. Our US-based team of senior medical device engineers works hand-in-hand with your staff to build documentation that regulators actually accept. With over 20 years of experience, we bring the depth of a global firm with the agility of a boutique consultancy.
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Start Your Project Tomorrow — Rapid onboarding, often within 24–48 hours of engagement.
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US-Based Senior Engineers — Not template factories. Real engineers with hands-on device experience.
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NDA-First & Confidential — Your IP and regulatory strategy stay protected from day one.
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Transparent, Fixed-Fee Pricing — No surprise bills. You know the scope and cost upfront.
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Multi-Jurisdiction Expertise — One partner for FDA, EU MDR, Health Canada, SFDA, and MDSAP.
20+
Years Experience
60+
Projects Delivered
100%
Client Satisfaction
24hr
Project Kickoff
Client Results
Trusted by Medical Device Teams Worldwide
From early-stage startups to established global manufacturers, we've helped teams across FDA, EU MDR, Health Canada, and SFDA markets achieve compliance on time and on budget.
"Regulatory Assist delivered a complete ISO 14971 risk management file in under three weeks — start to finish. Their engineers understood our surgical device inside and out. We passed our Notified Body audit without a single major nonconformity."
"We had a failed 510(k) submission when we came to Regulatory Assist. Their team overhauled our predicate strategy, strengthened our performance testing argument, and we received FDA clearance on the very next submission cycle. Worth every dollar."
"Fast, reliable, and deeply knowledgeable about SFDA requirements. Regulatory Assist guided us through the GHAD e-submission process and helped us achieve SFDA device registration in the Saudi market within four months — ahead of our launch deadline."
Our Process
How We Work
A proven, streamlined process that gets your device to market faster without compromising safety or compliance.
1
Discover & Assess
We start with a thorough gap analysis of your current documentation, risk files, and QMS. Within days, you receive a prioritized roadmap with clear milestones.
2
Build & Remediate
Our engineers work alongside your team to develop audit-ready documentation — risk files, SOPs, technical files — tailored to your specific device and target markets.
3
Deliver & Support
We hand off complete, submission-ready documentation and provide ongoing support through audits, renewals, and post-market surveillance activities.
FAQ
Frequently Asked Questions
Clear answers to the most common questions about medical device regulatory compliance, ISO standards, and working with our team.
ISO 14971 is the international standard for applying risk management to medical devices. It provides a systematic framework for manufacturers to identify hazards, estimate and evaluate risks, implement controls, and monitor their effectiveness throughout the product lifecycle. Most major regulatory bodies — including the FDA (21 CFR 820/QMSR), EU MDR 2017/745, Health Canada, and SFDA — require a compliant ISO 14971 Risk Management File as a prerequisite for device approval. Without it, your device cannot legally enter these markets.
The FDA's target review time for a standard 510(k) is 90 days from acceptance. Total time from submission to clearance typically ranges from 3–6 months, accounting for the acceptance review period, any Additional Information (AI) requests, and iterative correspondence. A well-prepared submission with a strong predicate device strategy and complete testing package significantly reduces the risk of AI requests — and speeds up your path to market.
ISO 13485 is the international QMS standard for medical device manufacturers, adopted across the EU, Canada, and most global markets. FDA 21 CFR Part 820 was the US-specific Quality System Regulation. In 2024, the FDA harmonised Part 820 with ISO 13485 through the Quality Management System Regulation (QMSR), making the two largely aligned. A compliant ISO 13485 QMS now satisfies most FDA QMS requirements — our consultants help you build one unified system that covers both simultaneously.
Yes — we provide end-to-end EU MDR 2017/745 support: Technical File (TF) and Design Dossier preparation, General Safety and Performance Requirements (GSPR) checklists, Clinical Evaluation Reports (CERs) following MEDDEV 2.7/1 Rev. 4, Post-Market Clinical Follow-up (PMCF) plans, Summary of Safety and Clinical Performance (SSCP), and Notified Body submission preparation. Whether you're transitioning from MDD or entering the EU market for the first time, our team ensures your documentation is complete before submission.
We work across a wide range of device types and risk classes: Class I, II, and III devices; Software as a Medical Device (SaMD); in-vitro diagnostics (IVD); implantables; surgical instruments; capital equipment; combination products; and connected wearables. Our engineers have hands-on experience across cardiology, orthopaedics, diagnostics, neurology, digital health, and ophthalmic sectors.
Most projects begin within 24–48 hours of engagement. After an initial consultation call we issue a Statement of Work (SOW), and upon NDA execution and project kickoff we immediately assign a senior engineer to your account. We maintain capacity for fast-start engagements because we know regulatory timelines are rarely flexible. Contact us today to discuss your timeline and device specifics.
Ready to Streamline Your Compliance?
Book a free consultation to discuss your device, timelines, and regulatory strategy.
Most projects begin within 24–48 hours. No templates. No generic advice. Just real engineering support.