Standards & Testing

Implement IEC 82304-1 for health software product safety, including product requirements, validation, cybersecurity, lifecycle management, IEC 62304 links, and FDA/EU MDR alignment.

Guide to ISO 11137 radiation sterilization for medical devices, covering gamma, e-beam, and X-ray methods, dose establishment, materials compatibility, validation, and dose audits.

Guide to ISO 14155:2026 for medical device clinical investigations, covering GCP expectations, risk management, committees, estimands, sponsor duties, adverse events, and post-market studies.

Guide to ISO 15223-1 medical device symbols and labeling, covering the 2025 EU REP amendment, MDR/IVDR requirements, symbol validation, categories, and implementation.

Guide to ISO 17665 steam sterilization, covering moist heat principles, IQ/OQ/PQ validation, F0 lethality, biological indicators, cycle design, autoclave qualification, and monitoring.

Use FDA recognized consensus standards in 510(k), De Novo, and PMA submissions — Declaration of Conformity, key standards, and common mistakes to avoid.

Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.

Plan human factors testing for devices with FDA guidance, IEC 62366-1, formative and summative studies, sample sizes, HF submission categories, and review-ready documentation.

Guide to IEC 60601-1 compliance for medical electrical equipment, covering basic safety, essential performance, collateral standards, EMC, FDA, EU MDR, testing, and Edition 4.

Validate medical device packaging to ISO 11607, including sterile barriers, material qualification, aging studies, distribution simulation, seal testing, and shelf-life claims.

Guide to BIS certification for medical devices in India, covering required standards, ISI marking, testing, Manakonline, CDSCO overlap, timelines, and costs.

Practical guide to ISO 10993-1:2025 changes, including risk-based biological evaluation, the new table framework, exposure duration updates, genotoxicity, and compliance steps.

Guide to ISO 13485 internal audits, including Clause 8.2.4 expectations, audit planning, checklists, auditor qualifications, nonconformities, CAPA linkage, and certification readiness.

Plan shelf life and stability testing for medical devices, including ASTM F1980 accelerated aging, real-time studies, sterile barrier testing, packaging validation, and expiration dating.

Implement medical device process validation with IQ, OQ, and PQ methods, FDA and GHTF expectations, statistical tools, master plans, and continued process verification.

Apply IEC 62366 usability engineering to medical devices, including the usability file, formative and summative evaluations, use-related risk analysis, FDA guidance, and EU MDR expectations.

A comprehensive guide to biological evaluation and biocompatibility testing under ISO 10993 — from categorization and test selection to chemical characterization and FDA expectations.

How to implement IEC 62304 for medical device software development — safety classification, lifecycle processes, SOUP management, documentation requirements, and practical tips for agile teams.