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
🇸🇦
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
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.
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.