Quality Systems
191 articles
EU MDR Post-Market Surveillance Plan: MDCG 2025-10 Practical Guide
Build a PMS plan aligned with MDCG 2025-10 guidance: proactive data collection, QMS integration, trend reporting, PMS reports vs PSURs, and custom-made device obligations.
21 CFR Part 4: Combination Product cGMP Quality Systems for Drug-Device Manufacturers
How drug-device combination product manufacturers implement quality systems under 21 CFR Part 4 — streamlined approach, QMSR update, design controls, stability, and EU MDR Article 117.
ISO 19011:2026: What the Updated Audit Standard Means for Medical Device Manufacturers
ISO 19011:2026 embeds hybrid auditing, digital evidence management, and updated auditor competence across the audit lifecycle — what ISO 13485 and QMSR programs need to update.
UK MHRA International Reliance Pathway: Draft Regulations 2026 Analysis
MHRA's draft Medical Devices Regulations 2026: International Reliance Pathway for US, Canada, and Australia approvals, IVD reclassification, PCCPs for AI software, and what manufacturers must prepare.
FDA 510(k) Exemptions for Unclassified Devices: June 2026 Guidance Update
FDA's June 5, 2026 guidance adds five unclassified device product codes to the 510(k) exemption list. Covers all 13 codes, enforcement policy, remaining obligations, and next steps.
Medical Device Cybersecurity Is Now a Procurement Gate: 2026 Hospital Buying Data
RunSafe's 2026 Index: 56% of hospitals reject devices over cybersecurity, 35% won't buy without an SBOM, and 84% include security in RFPs. What manufacturers must do now.
ISO 13485 Audit Findings: Most Common Nonconformities by Clause and How to Prevent Them
The ISO 13485 clauses most cited in audit findings — root causes and corrective actions for document control, CAPA, design controls, suppliers, internal audits, and process validation.
Medical Device Software Verification vs Validation: FDA and IEC 62304 Requirements
Software verification vs validation for medical devices — FDA expectations, IEC 62304 activities, documentation, traceability, and the design control process.
FDA 510(k) Guidance Documents: Device-Specific Requirements and Special Controls
How to find and use FDA 510(k) guidance documents, Class II special controls, device-specific submission requirements, and the CDRH FY 2026 guidance agenda to prepare stronger premarket submissions.
eDHR for Medical Devices: QMSR, Part 11 & Digital Manufacturing (2026)
eDHR implementation guide for medical device manufacturers: QMSR requirements, 21 CFR Part 11, MES integration, ISO 13485, paper-to-digital migration, and inspection readiness.
NAMs for Medical Device Biocompatibility: FDA, EU & ISO 10993 Guide (2026)
NAMs for medical device biocompatibility: FDA roadmap, EU phase-out plan, ISO 10993-5/-10/-23 in vitro alternatives, chemical characterization, and regulatory strategy.
Swissmedic 2026 PMS Focus Campaign: What Class IIa/IIb/III Manufacturers Must Prepare Now
Swissmedic 2026 PMS focus campaign guide for Class IIa, IIb, and III devices, covering PMS plans, PSURs, PMCF data, complaints, trend analysis, and preparation.
FDA 510(k) Exemptions for Class II Devices: 2026 Product Code Changes
Guide to 2026 FDA 510(k) exemption proposals and final notices for Class II devices, including affected product codes, exemption limits, criteria, and manufacturer next steps.
Medical Device Reshoring and Nearshoring Strategy Guide (2026)
Evaluate medical device reshoring and nearshoring decisions in 2026, including tariffs, QMSR and ISO 13485 implications, cost trade-offs, supply risk, and IP protection.
FDA Leadership Crisis 2026: Medical Device Regulatory Impact
Analysis of FDA Commissioner Marty Makary's reported May 2026 resignation, leadership departures, workforce losses, device review timeline risks, and manufacturer planning steps.
FDA Section 506J Device Shortage Reporting Guide
Understand Section 506J medical device shortage reporting, including mandatory notifications, the 506J list, OSCR oversight, and supply chain planning.
FDA READI-Home Innovation Challenge: Participation Guide
How medical device companies can join FDA's 2026 READI-Home challenge, including eligibility, phases, Q-submissions, and early engagement benefits.
CIRCIA for Medical Device Manufacturers: Cyber Incident Reporting to CISA
Prepare for CIRCIA cyber incident reporting rules, including 72-hour CISA reports, 24-hour ransomware payment notices, FDA overlap, coverage, and readiness steps.
UK MHRA 2026 Overhaul: CE Mark Recognition, DORS Fees and Clinical Trials
Overview of MHRA's 2026 device reforms, including CE mark recognition, DORS fees, clinical trial changes and manufacturer compliance steps for Great Britain.
Single-Use Device Reprocessing and Medtech Sustainability Guide
Assess single-use device reprocessing, circular economy benefits, hospital savings, carbon reduction, AMDR data, lifecycle evidence, EU MDR controls, and business case.