Standards & Testing

Practical guide to sample size justification for device clinical investigations, covering ISO 14155, EU MDR Annex XV, FDA IDE expectations, common study designs, and worked examples.

Develop a medical device SAP covering endpoints, estimands, analysis populations, missing data, sensitivity analyses, multiplicity, timing, and FDA/EU MDR expectations.

Meet IEC 62133 battery safety requirements for medical devices, including testing, FDA and EU MDR expectations, UN 38.3 transport, battery management, and risk controls.

Guide to wireless and RF compliance for connected medical devices, including FCC authorization, EU RED, coexistence testing, cybersecurity and global market access.

Guide to medical device endotoxin and pyrogen testing, including BET methods, rFC alternatives, ISO 11737-3, USP <85>/<161>, FDA guidance, and device limits.

Guide to bioburden testing under ISO 11737-1:2018, covering method validation, recovery efficiency, extraction, enumeration, dose setting, and routine monitoring for medical device sterilization.

Classify, design, validate, and monitor ISO 14644 cleanrooms for medical devices, including particle limits, environmental monitoring, FDA/EU GMP expectations, and 2025 updates.

Guide to EU MDR Common Specifications under Article 9, including Annex XVI products, IVD common specifications, conformity effects, and timelines through 2028.

Guide to EU MDR harmonised standards under Article 8, including the 2026 list, presumption of conformity, GSPR mapping, MDCG guidance, and compliance gaps.

Validate vaporized hydrogen peroxide sterilization under ISO 22441:2022, including FDA recognition, process parameters, material compatibility, validation protocols, and regulatory strategy.

Meet IEC 60601-1-2 EMC requirements for medical electrical equipment, including emissions, immunity, Edition 4.1, risk management, test plans, environments, and submissions.

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.