Risk
Risk thinking must stay connected
Teams need better linkage between quality events, change, and documented risk decisions.
Industry Page
Medical Devices
Connect design, risk, CAPA, training, and document control for device-focused quality systems.
Medical device manufacturers need ISO 13485–aligned QMS execution with ISO 14971 risk thinking visible in design changes, CAPA, and documentation — so training, records, and release decisions stay inspection-ready for notified bodies and FDA. The compliance hub stays centered on validation, data integrity, Part 11 records, and security — the evidence set device QA teams defend in audits.
Industry Challenges
The quality and compliance pressures unique to your regulated market — and how Complere is built to address them.
Training
Controlled roles and competency matter
Procedural updates and qualification gaps can quickly become inspection questions.
Visibility
Leaders need clear cross-process status
Backlogs, recurring issues, and design-impacting changes cannot remain siloed.
Regulatory Landscape
The regulatory frameworks, guidance documents, and audit expectations that govern quality operations in this sector.
Regulation
ISO 13485:2016
The international QMS standard for medical device manufacturers — covering document control, CAPA, training, internal audits, and supplier qualification throughout the product lifecycle.
Regulation
ISO 14971:2019
Risk management for medical devices — requiring documented risk identification, analysis, evaluation, mitigation, and residual risk acceptance at each stage of product design and change.
Regulation
FDA 21 CFR Part 820 (QMSR)
The FDA Quality Management System Regulation — the US quality system requirements for device manufacturers, updated in 2024 to align with ISO 13485 and harmonise global device QMS expectations.
Regulation
EU MDR 2017/745
The EU Medical Device Regulation — the mandatory framework for CE marking, post-market surveillance, clinical evaluation, and quality system requirements for devices sold in European markets.
Regulation
FDA 21 CFR Part 11
The FDA electronic records and electronic signatures regulation — governing audit trail requirements, access controls, signature meaning statements, and record integrity for digital quality systems.
Regulation
EU GMP Annex 11
The EU GMP computerized systems guideline — covering validation, audit trails, data integrity, access controls, and backup requirements for quality software used in regulated device manufacturing.
Relevant Modules
The Complere modules most commonly used by teams in this industry to manage compliance and quality operations.
Relevant Module
Document Control
Maintain design history files, device master records, and controlled SOPs under version-controlled lifecycle governance — meeting ISO 13485 document control requirements and FDA QMSR record accessibility expectations.
Learn moreRelevant Module
CAPA & Deviations
Investigate nonconformities with structured root cause analysis, link findings to ISO 14971 risk records, and track corrective actions through effectiveness review for ISO 13485 clause 8.5 compliance.
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Change Control
Assess design and process changes against EU MDR traceability requirements and QMSR impact criteria — with linked documentation, validation evidence, and approval sign-off captured in one traceable record.
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Management Review
Aggregate CAPA trends, audit findings, complaint data, and risk signals into ISO 13485–structured management review inputs — giving leadership the cross-module visibility required for clause 5.6 periodic review.
Learn moreRelated Resources
Explore related modules, compliance topics, and guides to build a complete picture of your quality system.
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Process accountability
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Audit trail glossary term
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ExploreSee how Complere supports ISO 13485 and ISO 14971 requirements
Our demos cover device-specific quality workflows — risk management, device history records, CAPA, and training competency — in your context.