A rare combination of legal training, business strategy, quality management mastery, and regulatory affairs certification — purpose-built for the complex world of medical device compliance.
Jared Clark, JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, RAC
Professional Background
Medical device quality management sits at one of the most complex intersections in the regulatory world — where engineering rigor meets regulatory compliance, where patient safety demands zero tolerance for quality failures, and where a single design control oversight can delay market access by months or trigger FDA enforcement. It requires a consultant who can think like an engineer, analyze like an attorney, manage like a project leader, and navigate regulatory pathways like a seasoned affairs professional.
That is exactly how Jared Clark approaches every ISO 13485 engagement. With a Juris Doctor (JD) providing deep legal and compliance analysis capability, a Master of Business Administration (MBA) driving strategic planning and business case development, and a Project Management Professional (PMP) credential ensuring disciplined implementation execution, Jared brings a foundation that most quality consultants simply do not have. But it is his specialized quality and regulatory credentials that make the real difference for medical device companies.
As a Certified Manager of Quality/Organizational Excellence (CMQ-OE) through ASQ, Jared holds the gold standard credential for quality management system leadership — validating his expertise across the full spectrum of QMS design, implementation, auditing, and continuous improvement. His Certified Pharmaceutical GMP Professional (CPGP) credential adds specialized knowledge of Good Manufacturing Practice requirements that overlap significantly with medical device production controls, sterile manufacturing, and process validation requirements under ISO 13485.
The Certified Food Safety & Quality Auditor (CFSQA) designation demonstrates Jared's rigorous audit methodology training — the same systematic, evidence-based approach he applies to ISO 13485 internal audits, supplier audits, and certification audit preparation. Medical device companies benefit from a consultant who has been trained to the highest auditing standards across multiple regulated industries.
Most critically for medical device companies, Jared holds the Regulatory Affairs Certification (RAC) from RAPS — the Regulatory Affairs Professionals Society. This is the defining credential for medical device regulatory professionals, and it means Jared does not just build your quality management system in isolation. He builds it with FDA regulatory strategy in mind from day one. Your ISO 13485 QMS becomes the foundation for 510(k) submissions, Design History Files, risk management documentation per ISO 14971, and post-market surveillance — because the same consultant understands both the quality system requirements and the regulatory submission pathway.
Over 8+ years of dedicated consulting practice, Jared has guided more than 200 organizations through successful management system certifications — maintaining a 100% first-time audit pass rate. His medical device clients range from early-stage startups building their first quality management system to established manufacturers expanding into new device classifications and international markets. He has implemented design controls for Class I, Class II, and Class III devices, developed risk management frameworks aligned with ISO 14971, prepared organizations for both ISO 13485 certification body audits and FDA facility inspections, and supported 510(k) regulatory submissions with the quality documentation foundation that FDA reviewers expect.
Jared's approach is hands-on, practical, and results-driven. He does not deliver a binder of generic templates and walk away. He works alongside your quality team to build a QMS that reflects your actual processes, your specific device portfolio, and your regulatory strategy — a system your team can operate, maintain, and improve long after certification is achieved. Every engagement is structured with clear milestones, defined deliverables, and a timeline that respects both regulatory urgency and organizational capacity.
Regulatory Affairs Certified (RAPS)
The gold standard credential for medical device regulatory professionals. Bridges ISO 13485 quality management and FDA regulatory strategy in a single consultant.
ISO 13485 + FDA 510(k) Integration
Your QMS provides the quality foundation for FDA regulatory submissions. Design controls, risk management, and DHF documentation support 510(k) clearance.
Legal + quality + regulatory in one consultant
Builds QMS with FDA submission strategy from day one
Hands-on implementation, not just templates
Class I, II, and III device experience
Professional Credentials
Seven professional credentials spanning law, business, project management, quality engineering, GMP compliance, audit methodology, and regulatory affairs — a breadth of expertise designed for the complex demands of medical device consulting.
Legal and compliance analysis. Regulatory interpretation, contract review, enforcement risk assessment, and product liability awareness for medical device manufacturers.
Strategic planning and business case development. Aligns quality management investment with commercial objectives, market access timelines, and organizational growth strategy.
Implementation project management. Structured milestone delivery, resource planning, risk mitigation, and timeline control for ISO 13485 certification projects.
Quality management systems expertise. QMS design, implementation, auditing, process optimization, and organizational excellence across the full management system lifecycle.
GMP and regulatory compliance. Good Manufacturing Practice expertise that directly applies to medical device production controls, process validation, and sterile manufacturing requirements.
Audit expertise and methodology. Systematic, evidence-based audit approach applied to ISO 13485 internal audits, supplier qualification audits, and certification audit preparation.
Medical device regulatory strategy. The defining credential for regulatory affairs professionals — ensuring your ISO 13485 QMS is built with FDA 510(k) submissions, EU MDR compliance, and global market access in mind.
Jared Clark is the founder of Certify Consulting, a full-service certification consulting firm serving manufacturers, healthcare companies, technology firms, and food producers across the United States. With credentials including JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, and RAC, Jared brings a unique combination of legal, business, and technical expertise to every engagement. ISO 13485 Expert is a specialized practice within the Certify Consulting network, focused exclusively on medical device quality management system certification.
This specialized focus means medical device companies get a consultant who lives and breathes the intersection of ISO 13485 quality requirements and FDA regulatory strategy — not a generalist who handles medical devices as one of many industries. From initial gap analysis through successful Stage 2 certification audit, every step is guided by deep domain expertise in design controls, risk management per ISO 14971, production and process controls, CAPA systems, and post-market surveillance. The result is a quality management system that not only achieves certification but serves as the foundation for ongoing FDA compliance and market expansion.
Schedule a free consultation to discuss your medical device quality management goals, assess your current readiness, and get a tailored roadmap to certification.
No commitment required. Expert guidance on your medical device QMS certification journey.