Quality Systems
241 articles
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.
EU MDR Technical File Deficiencies: Common NB Nonconformities
Guide to common EU MDR technical file deficiencies in Notified Body review, including clinical evidence gaps, risk management, PMS links, equivalence, and 2026/977 timelines.
FDA Medical Device Warning Letter Trends 2024-2026: Enforcement Analysis
Data-driven analysis of FDA medical device warning letter trends from 2024 to 2026, including common violations, QMSR shifts, notable actions, and compliance lessons.
DOJ Medical Device Fraud Enforcement 2026: FCA and Anti-Kickback Risks
Guide to DOJ medical device fraud enforcement in 2026, covering False Claims Act exposure, Anti-Kickback Statute compliance, AI-driven investigations, whistleblower risk, and executive controls.
Medical Device Cybersecurity Patch Management Guide (2026)
Plan regulated cybersecurity patch deployment for fielded devices under EU MDR, FDA Section 524B, and the Cyber Resilience Act, from triage to verified rollout.
Adhesive Bonding Process Validation for Medical Devices: From Variables to IQ/OQ/PQ
How to validate adhesive bonding for medical devices, including ISO 13485 and FDA QMSR requirements, UV and epoxy variables, IQ/OQ/PQ protocols, surface controls, and revalidation triggers.
Antibody Clone Lock and Lot-to-Lot Bridging for Immunoassay IVD Kits
How to lock antibody clones, manage lot-to-lot bridging studies, and maintain immunoassay IVD performance across manufacturing campaigns under FDA QMSR, ISO 13485, and EU IVDR.
Battery Cell Sourcing for Portable Medical Devices: Supplier Qualification
How to qualify battery suppliers and design medical device battery packs, covering chemistry selection, IEC 62133-2, UN 38.3, BMS controls, traceability, quality agreements, and dual sourcing.
Biological Specimen Sourcing for IVD Development: Serum, Plasma, Matrix
How to source serum, plasma, urine, CSF, and matrix materials for IVD calibrators and controls, covering donor qualification, viral testing, traceability, lot consistency, and regulatory expectations.
Calibrators and Controls Traceability for IVD Kits
How to establish traceability for IVD calibrators and controls, covering ISO 17511 hierarchy models, reference materials, commutability, uncertainty, value assignment, and regulatory expectations.
CDMO Quality Agreement RACI for Sub-Tier Supplier Control
How to structure RACI matrices in CDMO quality agreements for sub-tier supplier control, defining OEM, CDMO, and supplier accountability under ISO 13485, FDA QMSR, and EU MDR.