European Union

Step-by-step guide to EUDAMED registration — Actor Module (SRN), UDI/Device Module, Notified Bodies & Certificates, and Market Surveillance. Covers mandatory deadlines from May 2026, legacy device requirements, and compliance strategies.

Comprehensive guide to medical device change control — FDA design change requirements (21 CFR 820.30(i)), EU MDR significant changes (MDCG 2020-3), change classification, Notified Body notification, and change management best practices.

Comprehensive guide to medical device shelf life testing — accelerated aging per ASTM F1980, real-time aging studies, sterile barrier system testing, packaging validation, and expiration date justification for FDA and EU MDR submissions.

Comprehensive guide to medical device technical documentation — EU MDR Annex II & III requirements, FDA Design History File comparison, STED format, ISO 13485 medical device file, and step-by-step preparation instructions.

The complete guide to medical device clinical trials — FDA IDE requirements under 21 CFR 812, significant risk vs non-significant risk classification, IDE application process, study design, ISO 14155, costs, timelines, and practical strategies for regulatory professionals.

A comprehensive guide to PMCF under EU MDR — covering PMCF plan development, study design, evaluation reports, integration with PMS and clinical evaluation, and practical implementation strategies.

Complete guide to companion diagnostic device regulation — FDA CDx approval pathways, EU IVDR requirements, co-development with therapeutics, PMA/De Novo strategies, and real-world case studies from oncology to rare diseases.

Master FDA and EU MDR medical device labeling requirements, UDI system implementation, GUDID database submissions, and global UDI harmonization — practical guide with compliance checklists and common pitfalls.

Navigate the evolving medical device legislative landscape — from MDUFA V and the VALID Act to EU MDR implementation challenges, AI regulation, and global policy trends reshaping how devices reach patients.

Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.

How environmental sustainability, ESG reporting, and circular economy principles are transforming medical device design, manufacturing, and regulation — covering EU CSRD, FDA green initiatives, lifecycle assessment, and practical implementation strategies.

The complete guide to CE marking medical devices under EU MDR — classification, conformity assessment routes, Notified Body selection, technical documentation, and step-by-step process.

How to write a Clinical Evaluation Report that meets EU MDR requirements and passes Notified Body review — methodology, structure, literature search strategy, and common pitfalls.

The definitive guide to EU MDR (2017/745) and IVDR (2017/746) — covering classification rules, conformity assessment, technical documentation, EUDAMED, UDI, transition timelines, and practical strategies for manufacturers navigating CE marking in 2026.

How medical devices get reimbursed — coding systems, CMS coverage pathways, private payer strategy, health technology assessment, and building a reimbursement strategy from day one.

How to conduct performance evaluation under the EU IVDR — scientific validity, analytical performance, clinical performance, classification rules, and what Notified Bodies expect.