Medical Device & IVD Blog
FDA Clinical Decision Support Software: Device vs Non-Device Guide
Guide to FDA clinical decision support software policy, including Section 520(o)(1)(E), non-device CDS criteria, SaMD boundaries, examples, and digital health compliance steps.
FDA Establishment Registration & Device Listing: Complete Compliance Guide
Guide to FDA establishment registration and device listing under 21 CFR Part 807, including FURLS/DRLM, FY 2026 fees, who must register, annual renewal, and common violations.
FDA eSTAR Electronic Submission Template: Complete Guide to 510(k) and De Novo Submissions
Guide to FDA eSTAR electronic submission templates for 510(k) and De Novo, including mandatory use, template structure, completeness checks, submission methods, and common mistakes.
FDA Export Certificates for Medical Devices: CFS, CFG, COE Complete Guide
Guide to FDA export certificates for medical devices, including CFG, CFS, COE, CECATS applications, fees, eligibility, common mistakes, and global market access steps.
FDA Inspection Readiness for Medical Devices: Complete Guide to QMSR Inspections in 2026
How to prepare for FDA medical device inspections under the new QMSR framework (CP 7382.850) — inspection types, the six QMS areas, common 483 observations, and a step-by-step readiness checklist.
FDA PCCP Guide for AI/ML Medical Devices
Build FDA-ready Predetermined Change Control Plans for AI/ML devices, including PCCP components, submission strategy, examples, and implementation steps.
FDA QMSR Inspection Preparation: Complete Guide to Compliance Program CP 7382.850
Prepare for FDA QMSR inspections under CP 7382.850 with the six QMS areas, OAFRs, risk-based methods, ISO 13485 alignment, and readiness steps.
GMP vs cGMP for Medical Devices Under FDA QMSR
Understand GMP and cGMP expectations for device manufacturing under FDA QMSR, 21 CFR Part 820, ISO 13485, design controls, production, labeling, and inspections.
Humanitarian Device Exemption (HDE): Complete Guide to FDA Rare Disease Device Pathway
Use FDA's HDE pathway for rare disease devices, including HUD designation, probable benefit evidence, HDE applications, profit rules, IRB oversight, QMSR, and post-approval duties.
Hydrogen Peroxide Sterilization (ISO 22441): Complete VHP Guide for Medical Devices
Validate vaporized hydrogen peroxide sterilization under ISO 22441:2022, including FDA recognition, process parameters, material compatibility, validation protocols, and regulatory strategy.
IEC 60601-1-2 EMC Testing for Medical Devices
Meet IEC 60601-1-2 EMC requirements for medical electrical equipment, including emissions, immunity, Edition 4.1, risk management, test plans, environments, and submissions.
IEC 82304-1 Health Software Product Safety: Complete Compliance Guide (2026)
Implement IEC 82304-1 for health software product safety, including product requirements, validation, cybersecurity, lifecycle management, IEC 62304 links, and FDA/EU MDR alignment.
ISO 11137 Radiation Sterilization: Gamma, E-Beam, and X-Ray Guide
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.
ISO 13485 Implementation Guide: From Zero to Certification
Step-by-step guide to implementing ISO 13485 from scratch, covering QMS structure, clause requirements, documents, audit stages, costs, timelines, and FDA QMSR alignment.
ISO 14155:2026 Clinical Investigation of Medical Devices: GCP Guide
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.
ISO 15223-1 Medical Device Symbols: Complete Labeling and Marking Guide (2026)
Guide to ISO 15223-1 medical device symbols and labeling, covering the 2025 EU REP amendment, MDR/IVDR requirements, symbol validation, categories, and implementation.
ISO 17665 Steam Sterilization Guide for Medical Devices
Guide to ISO 17665 steam sterilization, covering moist heat principles, IQ/OQ/PQ validation, F0 lethality, biological indicators, cycle design, autoclave qualification, and monitoring.
LDT Regulatory Guide: FDA 2024 Rule Vacatur, CLIA Oversight, and Next Steps
Guide to LDT regulation after FDA's 2024 rule was vacated, covering CLIA oversight, enforcement discretion, ACLA litigation, and steps laboratories should take.
Management Review for Medical Devices: ISO 13485 & QMSR Compliance Guide
How to conduct management reviews for medical device companies per ISO 13485 Clause 5.6 and FDA QMSR — required inputs, outputs, frequency, documentation, and common audit findings.
PSUR Under EU MDR Article 86: 2026 Periodic Safety Update Report Guide
Prepare an EU MDR Article 86 PSUR with class-based frequency, MDCG 2022-21 structure, EUDAMED submission, PMS data, and benefit-risk analysis.