Regulatory

A practical walkthrough of all 7 IVDR classification rules in Annex VIII — with real device examples, software classification guidance, the IVDD-to-IVDR shift, and the 2025 EU simplification proposal that may reclassify certain IVDs.

Everything you need to know about EU MDR Notified Bodies and conformity assessment — how to select a Notified Body, assessment routes by device class (Annexes IX–XI), audit process, timeline, costs, and the 2025/2026 regulatory landscape.

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.

Everything you need to know about FDA Breakthrough Device Designation — eligibility criteria, application process via Q-Submission, program benefits, statistics, timeline, and how it applies to 510(k), De Novo, and PMA pathways.

Comprehensive guide to FDA medical device recalls — voluntary vs mandatory recalls, Class I/II/III classification, corrections and removals under 21 CFR 806, reporting requirements, recall strategy, health hazard evaluation, and compliance best practices.

Complete guide to FDA's Q-Submission program — Pre-Submissions, Submission Issue Requests, Information Meetings, how to request FDA feedback, what to include, timeline, fees, and strategies for productive FDA interactions.

Comprehensive guide to FDA Medical Device Reporting (MDR) — who must report, what events are reportable, 30-day and 5-day timelines, eMDR electronic submission, complaint handling integration, MAUDE database, and enforcement risks.

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 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.

Comprehensive guide to the leading medical device consulting firms in 2026 — covering regulatory affairs, quality systems, clinical strategy, and global market access. Includes detailed firm profiles, comparison tables, pricing insights, evaluation criteria, and a decision framework for choosing the right partner.

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.

The definitive guide to quality audits for medical devices — covering FDA QMSR inspections, ISO 13485 certification audits, EU MDR Notified Body audits, MDSAP, internal audits, supplier audits, audit findings classification, preparation timelines, and post-audit remediation.

A comprehensive roundup of the most impactful medical device regulatory changes, FDA actions, EU MDR/IVDR milestones, and industry trends shaping 2026 — and what to prepare for in 2027.

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.

The complete guide to artificial intelligence and machine learning in medical devices — FDA's AI/ML action plan, predetermined change control plans, SaMD classification, 510(k) and De Novo pathways, EU MDR requirements, and Good Machine Learning Practice.

The definitive guide to CAPA in the medical device industry — FDA 21 CFR 820.198, ISO 13485 clause 8.5, root cause analysis methods, CAPA process steps, effectiveness checks, and common audit findings.

Complete guide to the Device History File (DHF), Device Master Record (DMR), and Device History Record (DHR) — FDA requirements, ISO 13485 equivalents, contents, relationships, and practical implementation.