·9 min read
EU MDR Article 120 Legacy Devices: What You Must Do Before Deadline
EU MDR Article 120 transition deadlines for legacy devices. Understand your obligations, QMS requirements, and what happens if you miss the deadline.
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·10 min read
IEC 62304 Software Lifecycle: A Practical Guide for Medical Device Developers
IEC 62304 software development lifecycle requirements for medical devices. Software safety classes, documentation, and what FDA and EU MDR expect from your software team.
·10 min read
FMEA for Medical Devices: Step-by-Step ISO 14971 Risk Analysis
How to conduct a Failure Mode and Effects Analysis (FMEA) for medical devices under ISO 14971. Severity, probability, risk evaluation, and risk control documentation.
·9 min read
FDA 21 CFR 820 vs ISO 13485: Key Differences Explained
Compare FDA 21 CFR Part 820 QSR and ISO 13485:2016 QMS requirements. What changed under QMSR and how to build a harmonized quality system.
·10 min read
How to Pass a Notified Body Audit: EU MDR Preparation Guide
Prepare for your EU MDR Notified Body audit. Understand the audit stages, documentation requirements, common findings, and how to manage the audit process.
·10 min read
Class II Medical Device 510(k) Pathway: Complete Timeline and Checklist
Complete guide to the FDA 510(k) clearance pathway for Class II medical devices. Predicate selection, substantial equivalence, testing requirements, and realistic timelines.
·10 min read
IVDR Compliance for IVD Manufacturers: Everything You Need to Know
Complete guide to EU IVDR 2017/746 compliance for IVD manufacturers. Device classification, performance evaluation, EUDAMED, and transition deadlines.
·9 min read
Medical Device Process Validation: IQ OQ PQ Explained
How to conduct IQ, OQ, and PQ process validation for medical devices under FDA QMSR and ISO 13485. Validation protocols, acceptance criteria, and revalidation requirements.
·9 min read
FDA QSR to QMSR Transition: Action Items for 2026
Concrete action items for transitioning from FDA QSR to QMSR by February 2027. Gap analysis, documentation updates, training requirements, and inspection readiness.
·9 min read
Complaint Handling Procedure for Medical Devices: FDA 21 CFR 820.198 Guide
Build an FDA-compliant complaint handling procedure for medical devices. 21 CFR 820.198 and MDR 21 CFR Part 803 requirements, complaint investigation, and MDR reportability.
·8 min read
Medical Device Audit Trail Requirements: What FDA Expects
What FDA expects for medical device audit trails under 21 CFR Part 820 and QMSR. Electronic records, document control logs, and how audit trails are reviewed during inspections.
·9 min read
EU MDR Post-Market Clinical Follow-Up (PMCF): Requirements and Templates
EU MDR PMCF requirements under Article 61 and Annex XIV. What goes in a PMCF plan, PMCF evaluation report, and how to build a PMCF program that satisfies Notified Bodies.
·7 min read
FDA Establishment Registration and Device Listing: Step-by-Step Guide
How to complete FDA establishment registration and device listing for medical device manufacturers. Annual renewal requirements, 510(k) exemptions, and common mistakes.
·9 min read
Biocompatibility Testing for Medical Devices: ISO 10993 Complete Guide
How to conduct biocompatibility evaluation for medical devices under ISO 10993. Risk-based approach, material characterization, biological testing, and FDA submission requirements.
·8 min read
Medical Device Shelf Life Testing: Accelerated Aging Protocol Guide
How to conduct accelerated aging studies for medical device shelf life validation. ASTM F1980, Q10 method, real-time aging, and FDA submission requirements.
·8 min read
Internal Audit Program for ISO 13485: Setup and Execution Guide
How to build and run an internal audit program for ISO 13485:2016. Audit planning, auditor competency, conducting audits, nonconformance reporting, and CAPA integration.
·8 min read
How to Write a Design History File (DHF): FDA 21 CFR 820.30 Guide
What goes in a Design History File under FDA 21 CFR 820.30. DHF structure, required records, common gaps, and how to maintain a DHF that passes inspection.
·9 min read
Sterilization Validation for Medical Devices: ISO 11135 and ISO 11137
How to validate sterilization processes for medical devices. ISO 11135 (EtO) and ISO 11137 (radiation) requirements, bioburden, cycle development, and revalidation.
·8 min read
FDA De Novo Request Process: When and How to Use It
When to use FDA's De Novo classification pathway for novel medical devices. De Novo request preparation, decision criteria, and how De Novo clearance creates a 510(k) predicate.
·8 min read
EU MDR Unique Device Identification (UDI): EUDAMED Registration Guide
How to implement EU MDR UDI requirements and register devices in EUDAMED. UDI-DI and UDI-PI structure, issuing agencies, labeling requirements, and EUDAMED submission.
·9 min read
Medical Device Clinical Trials: FDA IDE Application Guide
How to design and submit an FDA Investigational Device Exemption (IDE) application. Significant vs non-significant risk, IDE content requirements, and study design considerations.
·8 min read
Risk Management File for Medical Devices: What Goes In It
What belongs in a medical device risk management file under ISO 14971:2019. Risk management plan, risk analysis, evaluation, controls, and residual risk documentation.
·8 min read
FDA Recall Classes and Procedures: What Medical Device Makers Must Know
FDA recall Class I, II, and III definitions for medical devices. When a recall is required, how to initiate one, recall strategy requirements, and FDA oversight of recall effectiveness.
·10 min read
Medical Device Corrective and Preventive Action (CAPA): FDA 21 CFR 820.100 Complete Guide
A complete guide to FDA 21 CFR 820.100 CAPA requirements for medical device manufacturers. Learn how to build a compliant CAPA procedure that satisfies FDA inspections and ISO 13485.
·10 min read
EU MDR Summary of Safety and Clinical Performance (SSCP): What Manufacturers Need to Know
A complete guide to the EU MDR Summary of Safety and Clinical Performance (SSCP) requirement for Class III and implantable devices. What must be included, how it is validated, and how to write one.
·10 min read
510(k) Substantial Equivalence: How to Identify and Document Your Predicate Device
How to identify, evaluate, and document a predicate device for FDA 510(k) substantial equivalence. What makes a valid predicate, how to handle performance differences, and common FDA rejection reasons.
·5 min read
March 30, 2026 - Regulatory Updates and Approvals in Medical Devices
Today’s regulatory updates include FDA approvals for a pulmonary hypertension detection algorithm, gene therapy for severe Leukocyte Adhesion Deficiency Type I, and an HIV screening assay from Roche.
·5 min read
March 27, 2026 - Key Regulatory Updates for Medical Device Professionals
Stay ahead of regulatory changes: photon-counting CT technology, EU MDR compliance, FDA approvals and initiatives.
·8 min read
QMSR Deadline: February 2027 — What Medical Device Companies Need to Know
The QMSR transition deadline is February 2, 2027. Learn what changed, what stays the same, and how to align your QMS with the new FDA requirements.
·10 min read
FDA 483 Observations: How to Respond (With Examples)
Received an FDA 483? Learn how to write an effective response, what FDA expects, common mistakes to avoid, and examples of good vs bad responses.
·9 min read
510(k) RTA: How to Avoid FDA Refuse to Accept
43% of 510(k) submissions get RTA'd. Learn the top reasons for Refuse to Accept, how to use FDA's RTA checklist, and what to include to pass screening.
·5 min read
March 26, 2026 - Key Medical Device Regulatory Updates
Stay ahead of regulatory changes with updates on photon-counting CT technology, FDA approvals, and MDR compliance.
·5 min read
March 26, 2026 - Regulatory Updates for Medical Device Professionals
Stay ahead of the curve with today's critical regulatory updates from major medical device companies and FDA approvals.
·8 min read
How to Respond to an FDA Warning Letter: Timeline, Format, and CAPA Requirements
What FDA expects in a Warning Letter response: 15-day timeline, response structure, root cause analysis standard, CAPA closure evidence requirements, and common mistakes that keep Warning Letters open.
·7 min read
FDA Adaptive Trial Design for Medical Devices
FDA now accepts adaptive designs, Bayesian methods, and master protocols for device pivotal studies. What changed and how to use it in your IDE and SAP.
·7 min read
PCCP for AI/ML Medical Devices: FDA Predetermined Change Control Plan
How to build a PCCP FDA will approve for AI/ML-based medical devices. What your change scope, performance bounds, and monitoring plan must specify.
·7 min read
Real-World Evidence for Medical Device FDA Submissions
How FDA's Real World Evidence program applies to device 510(k), De Novo, and PMA submissions. Data governance requirements and building RWE capability early.
·8 min read
FDA Medical Device Cybersecurity Requirements: 2023 Guidance for Submissions
What FDA's 2023 cybersecurity guidance requires in premarket submissions. SBOM, threat modeling, post-market monitoring, and what triggers a refusal to accept.
·8 min read
EU MDR and IVDR Compliance: What Medical Device Manufacturers Need to Know
EU MDR and IVDR requirements for medical device manufacturers. Clinical evaluation, technical documentation, notified body selection, and EUDAMED registration.
·8 min read
MDSAP Audit Preparation: What FDA, Health Canada, and TGA Investigators Look For
What MDSAP auditors actually examine across the 7 audit chapters. Common finding categories, preparation priorities, and how to structure your evidence packages.
·8 min read
Medical Device Design Controls: FDA QMSR §820.30 and ISO 13485 §7.3 Requirements
What FDA QMSR §820.30 and ISO 13485 §7.3 require for medical device design controls. Design inputs vs outputs, V&V requirements, DHF structure, design transfer, and common FDA 483 observations.
·8 min read
Post-Market Surveillance Plan Template for Medical Devices (FDA + EU MDR)
What your post-market surveillance plan must include under ISO 13485 §8.2 and EU MDR Article 83. PMCF obligations, PSUR requirements, and common PMS gaps FDA and notified bodies flag.
·8 min read
SaMD Regulatory Requirements: What FDA Expects from Software as a Medical Device
What FDA expects from Software as a Medical Device (SaMD): IEC 62304 classification, SOUP management, PCCP for AI/ML devices, cybersecurity submission requirements, and when a 510(k) is required.
·8 min read
Medical Device Supplier Qualification: FDA QMSR §820.50 and ISO 13485 §7.4 Requirements
What FDA QMSR §820.50 and ISO 13485 §7.4 require for medical device supplier qualification. Supplier evaluation, quality agreements, ASL, incoming inspection, and common FDA 483 observations.
·8 min read
Medical Device CAPA: Building a System FDA Investigators Can’t Fault
What FDA QMSR §820.100 and ISO 13485 §8.5 require for CAPA. Root cause vs symptom, effectiveness verification, trending for management review, and the top FDA 483 patterns in CAPA systems.
·5 min read
FDA Compliance Readiness Calculator: Know Where You Stand Before Your Next Submission
Free FDA compliance readiness calculator for medical device companies. Answer 8 questions and get your score plus recommended resources.
·10 min read
ISO 14971:2019 Risk Management for Medical Devices: Practical Implementation Guide
Practical ISO 14971:2019 risk management guide for medical devices. Learn pFMEA, residual risk evaluation, risk-benefit analysis, and key changes from the 2007 edition.
·10 min read
Selling in Both the US and EU? Here's How to Manage FDA and EU MDR Dual Compliance
Navigate FDA and EU MDR dual compliance for medical devices. Gap analysis framework, document control strategies, and timeline for selling in both US and EU markets.
·10 min read
MDSAP Audit Preparation: What FDA, Health Canada, and ANVISA Actually Look For
Prepare for your MDSAP audit with this guide covering all 5 regulatory authorities, the scoring model, audit sequence, and top preparation mistakes to avoid.
·10 min read
FDA 510(k) RTA Checklist: How to Submit Without Getting Refused to Accept
Complete FDA 510(k) RTA checklist to avoid Refuse to Accept. Learn what triggers RTA, predicate device selection, and common submission failures.
·9 min read
QMSR Transition Guide: How Medical Device Manufacturers Are Adapting to FDA Part 820 Changes
Step-by-step QMSR transition guide for medical device manufacturers. Learn the FDA Part 820 to ISO 13485 alignment timeline, common mistakes, and how to adapt your QMS.