Medical Devices

ISO 9001 and ISO 13485 share a common core but serve different purposes. Here is how to decide which standard fits your organization, and when it makes sense to run both.

ISO 9001:2026 is out. See what changed from 2015, the transition timeline, and which QMS procedures dual-certified medical device teams should review first.

Watch Aaron Lyon explain medical device release evidence, from product configuration to design reviews, verification, validation and approvals.

Watch short medical device documentation guides narrated by Aaron Lyon, with original procedure examples and links to full guides.

Compare the Software Development Plan, SaMD Development Procedure and five-document software bundle by lifecycle and supporting evidence needs.

Compare a process validation procedure, the four-procedure bundle and equipment qualification protocols. Choose by planning, evidence and equipment gaps.

Compare the standalone Design Control Procedure, the four-procedure bundle, a discounted set of individual design procedures and the DESIGN PLUS system by existing gaps and scope.

Find medical device procedures, bundles and protocols by the task you need to complete. Compare document scope and open relevant product pages.

Browse medical device guides for QMS, design, software, clinical evidence, manufacturing and validation, with checklists and relevant document links.

Choose hazardous-energy, biohazard and respiratory documentation by the actual task. Use a servicing example and identify necessary safety implementation.

Plan facility technology transfer with a baseline, difference assessment and readiness evidence. Distinguish it from design transfer before buying.

Connect labels, UDI, shelf-life evidence and CE conformity decisions. Use a claim-change example and compare individual procedures with the bundle.

Separate internal audits from external inspection coordination. Use a training-record example and current FDA inspection context to select procedures.

Separate EO/gamma validation, product adoption and load release. Use a new-product example and check what the sterilization bundle includes.

Plan implant final-cleaning PQ by residues, geometry and family rationale. Use a recessed-surface example and identify evidence beyond the protocol.

Plan biological evaluation by finished-device exposure and evidence gaps. Use a cleaning-agent change example and select documentation before tests.

Connect cleanroom qualification, monitoring, cleaning and gowning. Use a changed-workstation example and check the three-procedure bundle’s scope.

Plan bar-sealer OQ and PQ for pouch packaging. Use a handling-fold example, configuration records and focused protocol-selection guidance.

Compare tray-sealer OQ and PQ. Use a tray-flange example, study decision table and guidance on the paired editable protocols and their limits.

Separate packaging accelerated aging from the wider device shelf-life claim. Use a claim-to-evidence matrix and focused document-selection guidance.