Glossary Term
Design Controls
Definition
Design Controls are a set of formalized procedures that guide the development of medical devices to ensure they meet user needs, intended use, and regulatory requirements. They are mandated by regulatory agencies such as the FDA under 21 CFR Part 820 and EU MDR to ensure the safety, performance, and quality of medical devices.
Relevance to the MedTech Industry
Design Controls are critical for maintaining a structured and traceable approach to medical device development. They help MedTech companies mitigate risks, ensure compliance, and deliver devices that are safe and effective for their intended purpose.
Additional Information & Related Terms
Design History File (DHF) A compilation of records that demonstrate compliance with design controls.
Risk Management File Addresses potential hazards as part of the design control process.
Verification and Validation (V&V) Critical activities under design controls to ensure devices meet design specifications and user needs.
ISO 13485 A global standard that incorporates design control requirements for medical devices.