# Medical Device QMS (MDQMS) | Botable Glossary

https://www.botable.ai/glossary/medical-device-qms-mdqms

> A vendor-published glossary/explanatory article: useful as an introductory reference on MDQMS concepts and regulatory references. Suitable to quote for definitions and for identifying standards and regulation names, but regulatory or compliance decisions should be confirmed against official standards and regulatory texts.

## Summary

Defines a Medical Device Quality Management System (MDQMS) as an organizational framework of processes, procedures, responsibilities, and resources to ensure medical devices meet quality, statutory, and regulatory requirements; describes key components (Design Controls, CAPA, Risk Management, Documentation) and cites relevant standards and regulations (ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR, EU MDR).

## Audience

Quality and regulatory professionals (medical device manufacturers and teams responsible for QMS)

## Prompts this page answers

- What is a Medical Device Quality Management System (MDQMS)?
- What are the mandatory components of an MDQMS (design controls, CAPA, risk management, records)?
- Which international standards and regulations apply to a medical device QMS?
- What records are required under FDA QSR and how long must they be retained?
- How does ISO 13485 relate to FDA 21 CFR Part 820 and the EU MDR?

## Purpose

Educational — to explain what an MDQMS is, describe its mandatory components and regulatory basis, and highlight challenges and benefits of implementing one.

## Highlights

- A Medical Device QMS (MDQMS) is an organizational framework of processes, procedures, responsibilities, and resources to ensure devices meet quality and regulatory requirements.
- ISO 13485 is the international standard that defines specific requirements for an MDQMS.
- Design Controls, CAPA, Risk Management, and Documentation/Records (including DMR and DHR) are key mandatory components of an MDQMS.
- FDA 21 CFR Part 820 (QSR) governs device QMS in the U.S.; the FDA revised Part 820 into the Quality Management System Regulation (QMSR) effective Feb 2, 2026.
- ISO 14971 defines application of risk management to medical devices; records retention includes at least 15 years from release for commercial distribution (per the page).

## How to cite



## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- Medical Device QMS
- MDQMS
- ISO 13485
- ISO 14971
- CAPA
- Design Controls
- 21 CFR Part 820
- QMSR
- EU MDR
- Device Master Record
- Device History Record

## Key entities

- **Medical Device Quality Management System (MDQMS)** (other): The glossary term defined on the page as a framework of processes, procedures, responsibilities, and resources to ensure device quality and regulatory compliance.
- **ISO 13485** (other): The international standard that defines specific requirements for an MDQMS (stated on the page).
- **ISO 14971** (other): Standard that defines the application of risk management to medical devices (stated on the page).
- **FDA 21 CFR Part 820 / QSR** (other): U.S. Quality System Regulation governing medical device QMS (referenced on the page).
- **Quality Management System Regulation (QMSR)** (other): The revised FDA regulation (Part 820 revised in 2024; effective Feb 2, 2026) referenced by the page.
- **EU MDR (Regulation 2017/745)** (other): European Union Medical Device Regulation referenced as part of the regulatory basis for MDQMS.
- **Device Master Record (DMR)** (other): Mandatory record containing specifications and procedures for manufacturing a device type (stated on the page).
- **Device History Record (DHR)** (other): Mandatory record documenting production history for a specific batch, lot, or unit (stated on the page).
- **Botable** (organization): Site/brand hosting the glossary entry. — https://www.botable.ai/glossary/medical-device-qms-mdqms

## Metadata

- Type: article