ISO 13485 Certification and FDA QMSR Readiness for the Medical Device Industry Webinar Summary

View the free webinar recording on the topic of: ” ISO 13485 Certification and FDA QMSR Readiness for the Medical Device Industry” or read the summary below.

Moriah Seibert, Quality Consultant Covers:

- What is ISO 13485
- What is a QMS
- Who is ISO
- What Types of Businesses Should Get ISO 13485 Certified
- Why Businesses Should Pursue ISO 13485 Certification
- Regulatory Changes that Affect the Medical Device Industry
- Why is the FDA making changes to Medical Device Regulation
- What is the FDA’s Quality Management System Regulation (QMSR)
- How to Implement FDA’s QMSR

What is ISO 13485?

ISO 13485 is an international standard published by the International Organization for Standardization (ISO) for medical device Quality Management Systems (QMS).

The ISO 13485 standard is based off of the ISO 9001 standard, with medical device industry focused requirements added that have a focus on maintaining patient safety.

What is a QMS?

Evidence of the ability to manufacture high quality medical devices or medical device components in a controlled and consistent manner. Document justifications for inapplicability or alternative approaches. *If you didn’t document it, it didn’t happen*

Processes including:

Design
Manufacture
Packaging
Labeling
Storage
Installation
Servicing

Systems for:

Document Control
Training
Change Control
Design Control
Corrective and Preventive Actions (CAPA)
Vendor and Supplier Management
Customer Complaints
Adverse Event Reporting
Internal Audits
Product Traceability

Who is ISO?

ISO is the International Organization for Standardization. The ISO organization was founded in 1947 as a voluntary organization to develop standards that are agreed upon on a global level. Representatives from all over the world work together to harmonize and agree upon a standard for industries.

What Types of Businesses Should Get ISO 13485 Certified?

Medical device manufacturers
Contract manufacturers
Component & material suppliers
Distributors & logistics providers
Design and development firms
Sterilization & packaging providers
Installation & maintenance services for medical devices
Software developers for standalone or embedded medical device software
Companies looking to sell devices globally

Why Businesses Should Pursue ISO 13485 Certification?

Regulatory compliance – Domestic and International programs
Global market access
Quality & Process control
Risk mitigation
Competitive advantage
Improves internal communications & provides business continuity & structure
Supports design & development controls
Enhances supply chain relationships & oversight
Increases customer confidence, trust and satisfaction
Enables business growth and scalability
Supports the requirements of post-market surveillance & CAPA

Regulatory Changes that Affect the Medical Device Industry

For US businesses – FDA QMSR regulations go into effect February 2, 2026. The 21 CFR Part 820 regulations are directed at finished medical devices as poor quality has a high cost!

Market Delays
FDA Adverse Actions (483 Observations, Warning Letters, Injunctions)
Adulterated Product
Misbranded Product
Recalls

Why is the FDA making changes to Medical Device Regulation

FDA recognized that it needed to keep up! The last change to the FDA medical device regulation was in 1996, many things have changed with manufacturing and technology. FDA began the journey to update federal regulations in 2018, with the finished proposal up for public review and comments Feb 23, 2022.

By proposing to incorporate ISO 13485 by reference, the FDA is aligning with internationally recognized standards. The FDA can now enforce this previously “voluntary” standard. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.

What is the FDA’s Quality Management System Regulation (QMSR)

FDA’s QMSR (Quality Management System Regulation) is a rule that replaces the Quality System Regulation (QSR).

The Federal Regulation 21 CFR Part 820 is not changing numbers, but QMSR is to designate that the regulation has been updated. This change is focused on unifying US medical device regulations and standards with international best practice of ISO 13485 requirements.

Effective Feb. 2nd, 2026, some management records for medical device industry companies will be subject to FDA inspection, which will be a key change from the QSR.

How to Implement FDA’s QMSR

Perform a gap analysis of your QMS against ISO 13485: 2016 and the QMSR rule.
Revise and update your documents to align with the QMSR and ISO 13485: 2016 requirements, which focuses on risk management.
Train personnel on the updated QMSR requirements, so that your team can implement the necessary changes ahead of Feb. 2026.

ISO 13485 Certification and FDA QMSR Readiness for the Medical Device Industry Webinar Summary