Design Controls

This section covers the Schedule 5 requirements applicable to medical device manufacturers in India for this QMS element.

Schedule 5 Part I applies to all manufacturers (Class A–D). Part II applies to Class C and D manufacturers and includes additional requirements aligned with ISO 13485:2016.

Official source: Medical Devices Rules 2017, Schedule 5

Add a section detailing specific design control requirements such as: design planning requirements, design input specifications, design output documentation, design review procedures, design verification and validation activities, design transfer protocols, and design change control processes. Reference specific Schedule 5 sections applicable to different device classes.