Webinar: CAPA Under Scrutiny: What FDA Inspectors Really Look For in 2026
Discover your potential savings with our ROI Calculator
Self-guided Product Tours
Product Demo Videos
Pricing
Recent Analyst Insights
Featured Analyst Insights
2026 Gartner® Magic Quadrant™ for Quality Management System Software
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Datasheets
Brochures
Demo Center
Videos
Podcasts
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Compliance
Toolkits
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Events and Webinars
Events
Upcoming Webinars
Featured Event
PDA/FDA Joint Regulatory Conference 2026
14 Sep, 2026
Washington, DC
About
About ComplianceQuest
ComplianceQuest is the #1 AI-powered Quality, Risk, and Compliance (QRC) platform that connects Product, Quality, Manufacturing, People, Suppliers and Customers in a single system.
Built on Salesforce, the platform delivers end-to-end visibility, AI-driven intelligence, and enterprise-scale execution, enabling organizations to manage risk, ensure regulatory compliance, and turn quality into a driver of growth.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplianceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
FDA Finalizes Rule Integrating ISO 13485 into the New Quality Management System Regulation (QMSR) for Medical Devices
FDA ISO 13485 is a globally recognized standard that defines the requirements for a Quality Management System (QMS) specific to the medical device sector. This standard applies to the entire lifecycle of a medical device, covering its design, development, production, installation, and maintenance. Its primary goal is to ensure that medical devices are both safe and effective for their intended use. Many countries require compliance with FDA ISO 13485 as part of the regulatory approval process for medical devices. The standard is designed to be adaptable and scalable, making it suitable for organizations of different sizes and types within the medical device industry. For a comprehensive understanding, check out this in-depth ISO 13485 guide.
An FDA quality management system is the structured set of processes, documentation, and controls a medical device manufacturer uses to consistently design, produce, and distribute safe and effective devices while meeting FDA regulatory requirements. Since February 2, 2026, that structure is defined primarily by the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference into 21 CFR Part 820.
ISO 13485 matters because it's no longer just an internationally recognized best-practice standard - it's now the enforced baseline the FDA uses to evaluate US medical device manufacturers' quality systems. An organization's FDA quality management system needs to demonstrate:
Manufacturers already certified to ISO 13485:2016 have the smallest gap to close under the QMSR. Those who were complying only with the old Part 820 QSR face more significant changes, particularly around terminology, record structures, and adopting a more explicitly risk-based approach to quality processes.
FDA ISO 13485 is the most widely adopted international standard for quality management within the medical device industry. Issued by the International Organization for Standardization (ISO), it serves as an effective framework to meet the extensive requirements for a Quality Management System in the medical device sector. Here is more about ISO 13485 and its significance in ensuring medical device compliance.
Implementing FDA ISO 13485 provides manufacturers with a solid foundation to comply with the EU Medical Device Regulation (MDR) and other global regulations while showcasing their dedication to the quality and safety of medical devices.
The process begins with securing management support and identifying customer requirements for the QMS. Next, essential documentation must be developed, including the Quality Policy, Quality Objectives, and Quality Manual, which collectively define the system's scope and implementation. Additionally, organizations must establish the necessary mandatory and supplementary procedures to ensure proper product or service delivery.
For a detailed breakdown, refer to the article outlining the mandatory documents required by ISO 13485:2016. The ISO organization conducts an annual survey to track certifications for its management system standards.
This survey records the number of certificates issued by certification bodies accredited under the International Accreditation Forum (IAF). In 2021, there were 27,229 valid ISO 13485 Certifications worldwide, compared to 25,656 in 2020, as reported in the 2021 ISO Survey.
What’s New, What’s Mandatory, and How to Get Audit-Ready Fast FDA’s new Quality Management System Regulation (QMSR) represents the most…
In 2018, the US FDA had announced its plans to harmonize FDA Quality System Regulations (QSR) with ISO 13485:2016 quality…
The FDA’s recent amendments to 21 CFR 820 have introduced significant changes to the Quality Management System Regulation (QMSR) for…
FDA guidelines for a quality management system now center on the QMSR, which incorporates ISO 13485:2016 into 21 CFR Part 820, alongside the FDA's continuing requirements under 21 CFR Part 11 for electronic records and e-signatures. Together, these guidelines expect manufacturers to build a QMS around:
Safety and performance of medical devices are the most important in this highly regulated industry; this is why quality management systems are a regulatory or legal requirement in many countries. Implementing ISO 13485 can help organizations involved in any part of a medical device’s life cycle with the following:
Financial Benefits and Universal Recognition: FDA ISO 13485 has become the model QMS standard for the medical industry and is recognized by the Global Harmonization Task Force (GHTF). It has been found that QMS-certified companies experience proven improvements in financial performance as compared to uncertified ones. An ISO 13485 quality management system can help an organization:
Boost Customer Satisfaction: Many organizations implement ISO 13485 and obtain Certification because an organization with an efficient QMS will usually meet customer expectations better than organizations that do not have a proper QMS. If any organizations’ central focus is on the customer, then the organization spends less time focusing on individual goals of departments and more time working together to meet customer needs.
Internal Performance through Process Improvement: FDA ISO 13485 stresses management review, audit processes, and improved processes based on collected data. Using Audit Management Software for FDA and ISO 13485 Compliance, improvements can be planned and implemented efficiently, ensuring better operations, enhanced performance, and higher profitability.
Effective Decision Making & Involvement of Top Management: In an organization focused on quality goals, the management has access to data on a continual basis to see progress or lack thereof. With periodic Management Reviews (Clause 5.6), performance is evaluated against goals on a scheduled basis and appropriate action taken where required. To meet the requirements of the standard, top management involvement with regards to the FDA Quality Management System Medical Devices increases. To ensure implementation of the Quality Policy (Clause 5.3), the management can take action to make sure that the quality goals are met, new targets are set, and continual improvement is accomplished. The quality policy also ensures that corrective action must be taken whenever errors occur.
Employee Involvement: ISO 13485 requires that employees understand their role in the QMS. Better training and qualification of employees lead to performance consistency, increased involvement and productivity, and less scrap and rework. ISO 13485 creates a work environment with feedback and idea-sharing, allowing employees the opportunity to provide their thoughts on on-going processes.
The FDA Quality Management System for Medical Devices ensures the consistent production of high-quality and safe medical devices. This systematic framework minimizes defects and malfunctions, enhancing patient safety and reducing manufacturer liability.
Enforcing the FDA Quality Management System for Medical Devices (QMSMD) has numerous advantages for manufacturers of medical devices:
The stringent structure of the FDA Quality Management System Medical Devices guarantees the consistent production of top-tier medical devices, mitigating the risk of defects and malfunctions. This results in heightened patient safety and decreased liability for manufacturers.
The FDA QMS System for Medical Devices aligns seamlessly with international standards such as ISO 13485, facilitating a smooth journey toward regulatory compliance and market access. This simplifies the approval process, reducing the likelihood of regulatory delays or penalties.
The systematic approach of the FDA Quality Management System Medical Devices fosters process optimization, minimizing waste, and leading to cost savings. This not only improves manufacturing efficiency but also enhances overall organizational productivity.
Consistently delivering high-quality and safe products enables manufacturers to cultivate robust customer trust and satisfaction. This results in an augmented brand reputation and an expanded market share.
The FDA QMS System for Medical Devices underscores continuous improvement through data analysis and feedback mechanisms. Manufacturers can proactively identify and address quality issues, further refining their products and processes.
Implementing a QMSMD aligned with ISO 13485 opens avenues to global markets, enabling manufacturers to broaden their reach and market share. This encourages international collaboration and knowledge sharing within the medical device industry.
Requirements for regulatory purposes are becoming more stringent throughout every step of a product’s life cycle, including service and delivery. Organizations are expected to illustrate their QMS processes and ensure best practices in everything they do. For each QMS, the organization should:
Define the processes needed for the QMS and apply a risk-based approach.
Establish criteria and methods needed to ensure that both the operation and control of these processes are efficient.
Ensure the availability of information and resources essential to support the operation and monitoring of these processes.
Implement actions to achieve desired results and maintain the effectiveness of these processes.
Monitor, analyze, and measure the impact of these processes.
Since February 2, 2026, ISO 13485:2016 is incorporated by reference into 21 CFR Part 820 as the QMSR, meaning these process-oriented, risk-based requirements are no longer just an internationally accepted standard as they form the enforced baseline for FDA-regulated device manufacturers, with FDA-specific supplemental provisions layered on top.
An FDA QMS system built for QMSR and ISO 13485 compliance should include:
Controlled SOPs, work instructions, and specifications with full revision history and approval workflows.
Structured CAPA workflows with root cause analysis and effectiveness checks.
Complaint intake connected directly to Medical Device Reporting (MDR) evaluation, so reportable events aren't missed.
Supplier qualification, ongoing monitoring, and audit history connected to incoming inspection and CAPA data.
Risk assessments (aligned to ISO 14971 principles) linked directly to design inputs, outputs, and verification/validation records.
Role-based training assignments tied to document revisions, with completion tracking for audit purposes.
Scheduled internal audits and structured management reviews with documented follow-up actions.
21 CFR Part 11–compliant controls ensuring every record and approval is attributable and time-stamped.
Structured review and approval for process, product, or system changes, with validation documentation retained.
The ability to pull complete, organized compliance evidence on demand rather than reconstructing it during an inspection.
Implementing an FDA-compliant quality management system requires a structured, risk-based approach. The following steps help organizations align processes, documentation, technology, and employee responsibilities with FDA, ISO 13485, QMSR, and 21 CFR Part 11 requirements.
Define applicable FDA, ISO 13485, and QMSR requirements.
Identify which clauses and supplemental FDA provisions apply to your specific device classification and markets.
Map current SOPs and records.
Document how your existing processes handle design control, CAPA, complaints, and supplier quality today.
Run a QMSR/ISO 13485 gap assessment.
Compare current processes against the QMSR's requirements to identify where terminology, structure, or risk-based rigor falls short.
Prioritize high-risk gaps.
Address gaps with the greatest regulatory or patient-safety exposure first, rather than tackling every gap in parallel.
Configure document, CAPA, audit, complaint, supplier, and training workflows.
Build these as connected processes. A complaint should be able to trigger CAPA, which should be able to trigger a document update and training assignment.
Validate electronic systems and Part 11 controls.
Confirm e-signatures, audit trails, and access controls are validated and functioning as intended before go-live.
Train users by role.
Quality, regulatory, design, and production teams each need training tailored to how the QMS affects their specific responsibilities.
Monitor readiness using dashboards and internal audits.
Use real-time dashboards to track open CAPAs, overdue training, and audit findings, and run internal audits to verify the system operates as designed, not just that it exists on paper.
Manufacturers must follow and establish a QMS to ensure their products can meet desired requirements and specifications. The FDA has determined in the QS regulation the vital elements that a quality system shall incorporate, as the QS regulation includes a wide spectrum of production processes, devices, etc. Manufacturers should determine the necessity of some quality elements to develop and implement specific procedures tailored to their particular processes and devices.
Medical device training delivers the knowledge and skills that you need to comply with global requirements and boost your organization’s performance. By integrating with CQ Document Management, ComplianceQuest’s interactive and comprehensive training programs provide a learning experience for quality assurance or regulatory affairs professionals by giving appropriate permission for users on any device, anywhere, anytime.
We have implemented CQ in a new medical device start up. The set up and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485.
Some of the reasons why I would recommend the software are: – 100% cloud-based – Allow almost paperless Quality Management System – Excellent customer support – Simple set up and implementation – User friendly – Efficiency and security – Accessible cost for small companies.
Laura Granados,QMS Systems Development Consultant
Choosing an FDA-ready QMS means evaluating platforms against the specific demands of the QMSR transition, not just generic quality management features:
ComplianceQuest helps you organize your company’s ISO 13485:2016 requirements to manage and maintain applicable regulatory requirements for quality, regulations, and responsibilities, as well as demonstrate a commitment to the safety and quality of medical device products. Using Audit Management Software for FDA and ISO 13485 Compliance, organizations can streamline audits and documentation, making it easier to follow the ISO 9001 PDCA (Plan, Do, Check, Act) process model. This prescriptive approach supports a more robust QMS, improves productivity, and helps auditors and notified bodies find what they need quickly and effortlessly.
ComplianceQuest’s document management solution enables an organization to create, revise, collaborate, and maintain all important documents and medical device files and can provide the latest version to appropriate permission users on any device, anywhere, anytime.
ComplianceQuest also helps the top management to gain insights from the QMS embedded in their organization and maintain its effectiveness by monitoring operational and performance key metrics.
Is Your Internal Communication Related to QMS (ISO 13485) Adequate?
Checklist | September 27th, 2021
“Records” to be Maintained for an ISO 13485 Certified Device Manufacturer
Checklist | May 28th, 2021
FDA Quality System Regulation For Labelling
Checklist | May 18th, 2021
Review and Update Your QMS with 50 Mandatory SOPs as per ISO 13485:2016
Checklist | April 7th, 2021
Start by mapping your current SOPs, records, and workflows against ISO 13485:2016's clause structure and the QMSR's supplemental FDA provisions. Identify where your terminology, record structures, or risk-based processes fall short. This is typically the biggest gap for manufacturers who were previously relying only on the old Part 820 QSR. Prioritize gaps by regulatory and patient-safety risk, then build a remediation plan before configuring or migrating to new software.
Yes. Any electronic system used to maintain quality records, approvals, or signatures for an FDA-regulated medical device needs to meet 21 CFR Part 11 requirements, meaning validated e-signatures, complete audit trails, and controlled access. This is a separate requirement from ISO 13485/QMSR compliance itself, but the two work together: QMSR defines what your quality system must do, and Part 11 governs how electronic records within that system must be controlled.
Generally, all ISO standards are being reviewed every five years to establish if a revision is needed to keep it updated and relevant for the marketplace. ISO 13485:2016 is designed to address the latest QMS practices, including changes in regulatory requirements and technology. The revised version emphasizes on risk-based decision-making as well as changes related to the increased regulatory requirements for organizations in the supply chain.
The most recent update of ISO 13485 was released in March 2016. This revision introduced key enhancements, including a stronger emphasis on risk management, clearer definitions of management and training responsibilities, improved facility requirements, better alignment with regulatory design and development standards, stricter supplier control, strengthened traceability procedures, refined complaint handling processes, and updated product cleanliness requirements.
ISO 13485:2016 aligns with ISO 9001:2008, an internationally accepted standard for Quality Management Systems (QMS) established by ISO. While ISO 13485:2016 was introduced after the release of ISO 9001:2015, it does not conform to the latest ISO 9001 version. This decision was made because the updates in ISO 9001:2015 were deemed unnecessary for medical device standards.
Cloud-based QMS platforms like ComplianceQuest offer a scalable, efficient SaaS solution that helps organizations maintain compliance with FDA, ISO, and other regulations. By consolidating all compliance data into one unified system, businesses can standardize processes, strengthen audit readiness, and ensure consistent documentation across locations.
Automated workflows streamline incident reporting, CAPA, audits, and document control, reducing human error while improving accountability. Real-time dashboards and alerts enable proactive risk management, allowing teams to identify issues before they escalate.
As regulations evolve, ComplianceQuest’s cloud-native architecture makes updates seamless without costly upgrades. With complete traceability, electronic records, and instant audit trails, organizations can confidently navigate inspections and enhance overall operational compliance.
As of February 2, 2026, the FDA incorporates ISO 13485:2016 by reference into 21 CFR Part 820, now called the Quality Management System Regulation (QMSR). That means an ISO 13485 quality management system is no longer just good practice for the US market—its process-oriented, risk-based requirements form the baseline FDA enforces for design controls, supplier management, CAPA, and risk management. Companies already certified to ISO 13485 face the smallest transition. The FDA did add supplemental requirements where ISO 13485 doesn't fully align, so manufacturers should treat QMSR compliance as ISO 13485 plus those FDA-specific provisions, not as identical.
Manufacturers already aligned with ISO 13485:2016 face minimal impact, while those focused solely on the US market and complying only with the old 21 CFR Part 820 experience significant changes. The latter group has the most adaptation to do around terminology, record structures, and risk-based processes. A cloud-based QMS that maps controls to both ISO 13485 and the QMSR's supplemental requirements helps these organizations transition without rebuilding their quality system from scratch.
They used to be separate frameworks—ISO 13485 was the global voluntary standard, while 21 CFR Part 820 (the old Quality System Regulation) was the mandatory US rule. As of February 2, 2026, the old QSR was removed from Part 820 and the QMSR came into full force, incorporating ISO 13485:2016 by reference. In practical terms, Part 820 now points directly to ISO 13485 for most quality system requirements, harmonizing US expectations with the international standard used by other regulators and the Medical Device Single Audit Program.
Not on its own. ISO 13485 certification demonstrates a conforming quality management system, but certification alone does not exempt manufacturers from FDA inspections, and the FDA assesses firms using its own updated inspection model. The QMSR also layers FDA-specific requirements—such as device labeling, unique device identification, and certain record-keeping provisions—on top of ISO 13485 where the standard doesn't fully cover them. Manufacturers should not assume the QMSR is identical to ISO 13485. Certification is a strong foundation, but full FDA compliance means meeting those supplemental provisions too.
Yes, for finished device manufacturers. Under the QMSR, compliance with ISO 13485:2016 is now a legal requirement rather than a voluntary option for devices marketed in the US. The regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Formal third-party certification isn't itself mandated by the FDA, but because Part 820 now incorporates the standard by reference, manufacturers must operate a quality management system that meets ISO 13485's requirements alongside the FDA's supplemental provisions to lawfully market devices domestically.
The US FDA has retired its QSIT (Quality System Inspection Technique) requirements for medical devices and introduced the Quality Management…
On January 31, 2024, the US Food and Drug Administration…
A US-based manufacturer and supplier of packaging materials (blister packaging,…
The COVID-19 pandemic was an eye-opener. Despite all the advancements…
Learn about all features of our Product, Quality, Safety, and Supplier suites. Please fill the form below to access our comprehensive demo video.
Please confirm your details
By submitting this form you agree that we can store and process your personal data as per our Privacy Statement. We will never sell your personal information to any third party.
Enter Captcha