# Change Assessment | Botable Glossary

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

> A concise glossary/educational entry from a vendor site summarizing industry practices and regulatory considerations; useful as a high-level reference but not a substitute for primary regulatory guidance or official FDA/EU documents. Attribute statements to the Botable glossary when quoting.

## Summary

Change Assessment is the formal evaluation an organization performs to determine the impact of proposed modifications to products, documentation, procedures, facilities, or quality systems, ensuring changes are safe, effective, and compliant. The page describes core steps (identification/documentation, review/approval, verification/validation) and regulatory triggers relevant to medical devices (FDA 510(k), PMA supplements, EU MDR).

## Audience

quality and regulatory professionals (e.g., QMS teams in medical device and regulated industries)

## Prompts this page answers

- What is a Change Assessment in a Quality Management System?
- What are the core components of a Change Assessment for medical devices?
- When does a change to a medical device require a 510(k) or PMA supplement?
- How should verification and validation be applied during a change assessment?

## Purpose

Define the term 'Change Assessment' and explain its core components and relevant regulatory considerations, primarily for quality and regulatory contexts.

## Highlights

- Change Assessment (also called Change Control or Change Management) is the formal evaluation to determine the impact of proposed modifications to products, documentation, procedures, facilities, or quality systems.
- Core components: identification and documentation, review and approval, verification and validation.
- Verification/validation is required for changes to design, production processes, or software; HCT/P process changes require verification/validation to avoid adverse impacts.
- Regulatory triggers: FDA 510(k) if modifications could significantly affect safety/effectiveness; PMA supplements for certain changes to Class III devices; EU MDR requires assessment of safety/performance and may require new conformity assessment if intended use or risk classification changes.

## How to cite

Botable Glossary — 'Change Assessment' (link to https://www.botable.ai/glossary/change-assessment)

## Publisher

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

## Topics

- change assessment
- change control
- quality management system
- 510(k)
- PMA
- EU MDR
- verification and validation
- HCT/P

## Key entities

- **FDA** (organization): Referenced regarding premarket review (510(k)).
- **EU MDR** (other): European Union Medical Device Regulation; referenced for conformity assessment requirements.
- **Quality Management System (QMS)** (other): Referenced as the system in which change assessment activities are integral. — https://www.botable.ai/teams/quality-regulatory
- **HCT/P** (other): Human cells, tissues, and cellular and tissue-based products; mentioned in validation examples.

## Metadata

- Type: article