MedDeviceGuide — IVD & Medical Device Knowledge Base
ISO 13485 Certification: Complete Guide for Medical Device Companies
Guide to ISO 13485 certification requirements, audit process, costs, timelines, registrar selection, common findings, and alignment with FDA QSR, EU MDR, and MDSAP.
Software as a Medical Device (SaMD): The Complete Regulatory Guide
Guide to SaMD regulation covering IMDRF classification, FDA and EU MDR pathways, IEC 62304, IEC 82304-1, AI/ML change control, cybersecurity, and global frameworks.
The Complete Guide to FDA 510(k) Submissions
Practical FDA 510(k) submission guide covering predicate selection, substantial equivalence, eSTAR formatting, user fees, common deficiencies, and first-time filing tips.
Brazil ANVISA Medical Device Registration: The Complete Guide
How to register medical devices with ANVISA — classification, B-GMP via MDSAP, registration pathways, documentation, fees, and practical guidance for the Brazilian market.
Clinical Evaluation Report (CER) for Medical Devices: The Complete Guide
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.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.
FDA's QSR to QMSR Transition: What Medical Device Companies Need to Know
The FDA is aligning its Quality System Regulation with ISO 13485. Here's what the QMSR final rule means for your quality management system and what you need to do to prepare.
South Korea MFDS Medical Device Approval: The Complete Guide
Navigate South Korea's medical device regulatory system — MFDS classification, KGMP, approval pathways, clinical requirements, and practical market entry guidance.
Australia TGA Medical Device Registration: The Complete Guide
How to register medical devices with Australia's TGA — classification, ARTG inclusion, sponsor requirements, MDSAP, fees, and practical guidance for the Australian market.
EU MDR and IVDR: The Complete Guide to European Medical Device Regulation
Complete guide to EU MDR and IVDR for medical device and IVD manufacturers, covering classification, conformity assessment, UDI, EUDAMED, timelines, and CE marking.
ISO 10993 Biocompatibility Testing for Medical Devices: The Complete Guide
A comprehensive guide to biological evaluation and biocompatibility testing under ISO 10993 — from categorization and test selection to chemical characterization and FDA expectations.
FDA Medical Device Classification: Product Codes, Device Classes, and Regulatory Pathways
How FDA classifies medical devices into Class I, II, and III — product codes, regulation numbers, how to determine your device's classification, and what it means for your regulatory pathway.
India CDSCO Medical Device Registration: The Complete Guide
How to register medical devices with India's CDSCO — MDR 2017 classification, import licensing, BIS requirements, clinical evidence, and practical market entry guidance.
Post-Market Surveillance for Medical Devices: The Complete Guide
Guide to medical device post-market surveillance, including FDA and EU MDR/IVDR requirements, PMS plans, PMCF, PSURs, vigilance, and system design.
Design Verification vs. Validation for Medical Devices
Clear guide to medical device design verification and validation under FDA design controls and ISO 13485, covering V-model methods, documentation, examples, and common 483 findings.
IEC 62304 Medical Device Software Lifecycle: The Complete Implementation Guide
How to implement IEC 62304 for medical device software development — safety classification, lifecycle processes, SOUP management, documentation requirements, and practical tips for agile teams.
UK Medical Device Regulation Post-Brexit: UKCA Marking, MHRA & The Complete Guide
Navigate UK medical device regulation after Brexit — MHRA framework, UKCA vs CE marking, UK Responsible Person, Northern Ireland Protocol, and practical compliance guidance.
Ethylene Oxide (EO) Sterilization for Medical Devices: The Complete Guide
A comprehensive guide to EO sterilization — process development, ISO 11135 validation, residuals testing, environmental compliance, and how it compares to alternative sterilization methods.
Medical Device Registration in Southeast Asia: ASEAN Harmonization & Country Guide
Navigate medical device registration across ASEAN — the AMDD framework, country-by-country requirements for Indonesia, Thailand, Malaysia, Philippines, Vietnam, and Singapore.
Medical Device Reimbursement: The Complete Guide to Coding, Coverage, and Payment
How medical devices get reimbursed — coding systems, CMS coverage pathways, private payer strategy, health technology assessment, and building a reimbursement strategy from day one.