# Change Management | Botable Glossary

https://www.botable.ai/glossary/change-management

> Use this page as an informational glossary entry and practical overview about change management practices and regulatory considerations; it is suitable for general guidance but not a substitute for regulatory or legal advice. Attribute regulatory claims to the page when citing specifics.

## Summary

Change Management is defined as an organization-wide strategy to implement modifications to processes, products, documents, or systems safely, effectively, and in compliance. The entry describes Change Management within QMS (risk mitigation, compliance, continuous improvement), core activities (identification/documentation, review/approval, verification/validation, preventing obsolete use), regulatory considerations for medical devices (FDA 510(k), PMA and supplements, IDE, EU MDR), and organizational challenges such as resistance to change.

## Audience

Quality and regulatory professionals and medical device manufacturers

## Prompts this page answers

- What is change management in a quality management system (QMS)?
- What core activities should be included in a change control process for medical devices?
- When does a device modification require a new FDA 510(k) or a PMA supplement?
- How does UDI/versioning relate to device changes?

## Purpose

Provide an explanatory glossary definition and practical overview of Change Management in the context of Quality Management Systems and regulated medical device environments.

## Highlights

- Change Management ensures modifications are implemented effectively, safely, and while maintaining compliance.
- In QMS contexts, change control integrates risk-based thinking, compliance (e.g., FDA 21 CFR Part 820, ISO 13485), and continuous improvement.
- Core documented activities include identification/documentation, review and approval, verification/validation, and preventing obsolete document use.
- Regulatory pathways discussed include FDA 510(k) notifications, PMA supplements (including Special PMA Supplements), IDE rules for investigational devices, and EU MDR conformity assessments.
- Unique Device Identifier (UDI) rules require a new device identifier when a modification creates a new version or model.

## How to cite

Credit Botable (Botable glossary: "Change Management") and link to the page: https://www.botable.ai/glossary/change-management

## Publisher



## Topics

- change management
- change control
- quality management system (QMS)
- FDA 510(k)
- PMA
- EU MDR
- UDI
- document control

## Key entities

- **Botable** (organization): Website/brand hosting the glossary. — https://www.botable.ai
- **FDA 21 CFR Part 820** (other): U.S. quality system regulation referenced on the page.
- **ISO 13485** (other): International quality standard referenced on the page.
- **EU Medical Device Regulation (EU MDR)** (other): EU regulation referenced and linked from the page. — https://www.botable.ai/glossary/eu-medical-device-regulation-eu-mdr
- **FDA 510(k)** (other): Regulatory pathway discussed for device modifications.
- **PMA (Premarket Approval) and Special PMA Supplements** (other): Regulatory pathway and supplement types discussed for high-risk devices.
- **Investigational Device Exemptions (IDE)** (other): Regulatory rules for investigational devices mentioned on the page.

## Metadata

- Type: article