Achieve ISO 13485 certification to build a compliant quality management system for your medical devices. Expert guidance from gap analysis through successful certification audit — with FDA regulatory pathway support.
Jared Clark, JD, MBA, PMP, CMQ-OE, RAC — Medical Device Quality Consultant
Regulatory Affairs Certified (RAPS)
The gold standard credential for medical device regulatory professionals. Qualified to address both ISO 13485 quality management and FDA regulatory strategy.
ISO 13485 + FDA 510(k) Integration
Your ISO 13485 QMS provides the quality foundation for FDA regulatory submissions. Design controls, risk management, and DHF documentation support 510(k) clearance.
Understanding the Standard
ISO 13485 is the international standard for Quality Management Systems specific to medical devices. It specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices — with integrated risk management and regulatory compliance throughout.
Structured design and development process with planning, inputs, outputs, review, verification, validation, and transfer requirements per Clause 7.3.
Integration with ISO 14971 for product risk analysis, evaluation, and control throughout the entire medical device lifecycle.
Meet FDA QSR/QMSR requirements, EU MDR expectations, and global market access requirements through a single quality system.
Complete traceability from raw materials through manufacturing, distribution, and post-market surveillance for every medical device.
Unique Differentiator
Most medical device companies need both ISO 13485 certification and FDA regulatory clearance. Your quality management system isn't just about compliance — it's the foundation for successful 510(k) submissions, design history files, and post-market surveillance.
ISO 13485 consulting is a premium specialty within Certify Consulting, our full-service certification practice. With both RAC (Regulatory Affairs Certification) and CMQ-OE credentials, Jared bridges the gap between quality management and regulatory strategy.
ISO 13485 & FDA 510(k)FDA 510(k) Foundation
Your ISO 13485 design controls produce the Design History File (DHF) required for 510(k) substantial equivalence submissions.
FDA QMSR Harmonization
The FDA's new Quality Management System Regulation aligns with ISO 13485, making certification increasingly valuable for US market access.
Risk Management (ISO 14971)
Integrated risk management throughout product realization — your risk management file is a critical component of both ISO 13485 compliance and FDA submissions.
EU MDR Market Access
ISO 13485 certification is required for CE marking under the EU Medical Devices Regulation — essential for European market access.
Our Process
A structured, proven methodology that gets medical device companies certified in 6 to 12 months with a 100% first-time audit pass rate.
Comprehensive assessment of your current quality system against ISO 13485:2016 requirements, including design controls, risk management, and regulatory readiness.
Develop quality policy, quality manual, document control system, and the full documentation framework tailored to your device portfolio and regulatory requirements.
Implement Clause 7.3 design and development controls: planning, inputs, outputs, reviews, verification, validation, transfer, and design history file structure.
Deploy purchasing controls, production controls, CAPA system, complaint handling, monitoring and measurement, and train your team on QMS procedures.
Conduct comprehensive internal audits, perform management review, and resolve any nonconformities to ensure audit readiness.
Guide you through Stage 1 (documentation review) and Stage 2 (implementation audit) certification audits with confidence. 100% first-time pass rate.
Medical Device Companies
ISO 13485 applies to any organization involved in the lifecycle of medical devices — from design and manufacturing to distribution and servicing.
Building your first QMS from scratch. Get it right the first time with a system designed for both ISO 13485 certification and FDA submissions.
Class I, II, and III medical device manufacturers needing certification for market access, customer requirements, and regulatory compliance.
OEM and contract manufacturers needing ISO 13485 to qualify as suppliers to medical device companies and meet customer audit requirements.
Companies seeking CE marking under the EU Medical Devices Regulation (MDR). ISO 13485 certification is a prerequisite for notified body assessment.
Companies manufacturing sterile medical devices with additional ISO 13485 requirements for sterilization validation, cleanroom controls, and packaging.
SaMD developers needing ISO 13485-compliant quality systems for regulatory clearance, with software lifecycle processes per IEC 62304.
Your Consultant
Medical device quality management demands specialized expertise at the intersection of quality systems, regulatory affairs, and legal compliance. Jared brings a rare combination of credentials that covers all three.
Regulatory Affairs Certified (RAC)
RAPS credential specifically for medical device regulatory professionals. Qualified to address both ISO 13485 quality and FDA regulatory strategy for your devices.
Quality Excellence (CMQ-OE)
ASQ's Certified Manager of Quality/Organizational Excellence validates deep expertise in management systems, process improvement, and quality engineering.
Legal & Business Expertise (JD, MBA, PMP)
Medical device regulation has significant legal implications — 510(k) submissions, FDA enforcement actions, product liability. A law degree adds critical legal risk perspective.
Common Questions
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.