Practical guidance on ISO 13485 implementation, FDA compliance, design controls, and quality management systems for medical device companies. Written by an industry expert with RAC, CMQ-OE credentials.
From navigating the fundamentals of ISO 13485 to advanced regulatory strategy, our articles bridge the gap between standard requirements and real-world implementation. Each piece draws on hands-on consulting experience across 200+ medical device companies. For a full suite of quality and regulatory services, visit Certify Consulting.
FDA reclassified the von Willebrand factor assay as Class II under 21 CFR 864. Here's what IVD manufacturers should expect from the special controls, pending the codified regulation text.
FDA finalized 21 CFR 876.5940 for ingestible constipation devices on June 1, 2026. Here's what changed, the special controls, and your compliance path.
FDA created 21 CFR 868.1980 for AI nerve-block ultrasound overlays. Here's what changed, the four special controls, and how to plan your submission.
FDA is advancing DHTs in clinical investigations under PDUFA VII. Learn what this means for your drug or biologics program and how to stay compliant.
FDA issued an RFI on advancing digital health technologies in clinical investigations (due June 1, 2026). What device manufacturers, SaMD developers, and ISO 13485-certified organizations need to know.
Need an ISO 13485 consultant for medical devices? Learn what to look for, how the certification process works, and why Certify Consulting has a 100% first-time pass rate.
FDA denied Vanda Pharmaceuticals' NDA for Tradipitant (gastroparesis). Learn what the refusal-to-approve process means for your drug pipeline. Expert analysis inside.
FDA upheld its refusal to approve Vanda's NDA 218489 for tradipitant (gastroparesis) and denied the hearing request. Expert analysis of the regulatory battle, clinical evidence standards, and lessons for drug development teams.
Find out which children's and general-use products require CPSC eFiling starting July 2026. Expert guidance from Jared Clark at Certify Consulting.
FDA's final guidance on voluntary patient preference information reshapes medical device strategy. Learn what it means for your QMS and submissions. Expert analysis inside.
FDA's final guidance on incorporating voluntary patient preference information over the total product life cycle replaces the 2016 version and expands PPI's role from 510(k) to postmarket enforcement. Here's what ISO 13485 manufacturers need to know.
FDA's March 2026 correction to a 72-ANDA withdrawal notice reveals a critical lesson: ANDA holders must actively monitor Federal Register publications and act before effective dates. Here's what happened and why it matters.
FDA's proposed information collection for advisory committees is open for comment. Learn what it means for medical device makers and how to respond. Expert analysis inside.
FDA seeks comments by May 22, 2026 on advisory committee membership collections. Learn how CDRH's 18 MDAC panels shape device clearances and your QMS strategy.
FDA's CNPV Pilot Program promises faster NDA, BLA, and supplement reviews. Learn what it means for your regulatory strategy and how to prepare. Expert analysis inside.
Master ISO 13485 training requirements: competence records, effectiveness evaluation, and audit-ready documentation. Expert guidance from Certify Consulting.
Learn how to handle Field Safety Corrective Actions (FSCAs) under ISO 13485. Step-by-step guidance, regulatory requirements, and expert tips. Get audit-ready today.
Master ISO 13485 document control with expert procedures, ready-to-use templates, and the top audit findings to avoid. Get compliant faster—contact Certify Consulting.
FDA filed the IACM petition (CAP 5C0340) to remove methylene chloride, TCE, and ethylene dichloride from color additive regulations. Comment deadline: June 1, 2026. Here is what medical device manufacturers must do now.
Master ISO 13485 management review requirements: required inputs, expected outputs, and audit-ready frequency. Expert guidance from Jared Clark at Certify Consulting.
Learn what manufacturers must track under ISO 13485 and EU MDR post-market surveillance. Expert guidance from Certify Consulting. Start your PMS program today.
Master ISO 13485 traceability: UDI, lot numbers, and Device History Records explained. Avoid audit failures with Jared Clark's expert guidance. Learn more.
FDA's final order reclassifies melanoma detection devices (OYD, ONV) from Class III to Class II. Learn the compliance steps, deadlines, and what changes for your QMS.
FDA delayed the effective date of its spirulina extract color additive expansion rule. Learn what changed, key deadlines, and compliance steps for food manufacturers.
Master your ISO 13485 internal audit with our clause-by-clause checklist. Avoid nonconformities, pass first time, and stay audit-ready. Get expert guidance.
Master ISO 13485 process validation for sterile medical devices. Learn IQ, OQ, PQ protocols, sterilization requirements & audit strategies. Expert guide by Jared Clark.
Master ISO 13485 supplier controls — qualification, monitoring, and purchasing requirements. Expert guidance from Jared Clark to pass your next audit. Learn more.
Master ISO 13485 complaint handling from intake to MDR reporting. Expert guidance on clause 8.2.2 requirements, workflows, and audit-ready documentation.
Master ISO 13485 software validation requirements. Learn how IEC 62304 and CSV intersect, what auditors check, and how to build a compliant validation strategy.
Learn how medical device startups can build an ISO 13485-compliant QMS from scratch. Expert guidance on phasing, documentation, and first-time audit success.
The FDA QMSR aligns 21 CFR Part 820 with ISO 13485. Learn what changed, what it means for your QMS, and how to prepare. Expert guidance from Certify Consulting.
Master CAPA under ISO 13485. Learn corrective and preventive action requirements, root cause methods, and audit-ready documentation. Expert guidance inside.
Master ISO 13485 clause 7.3 design controls with practical implementation steps, templates, and expert tips. Learn what auditors look for. Free guidance.
Learn how ISO 13485 certification strengthens your FDA 510(k) submission.
Learn how ISO 14971 and ISO 13485 work together for medical device risk management. Practical integration strategies from a certified QMS expert.
Learn what ISO 13485 certification actually costs — from gap assessments to surveillance audits. Budget breakdowns, timelines, and expert guidance from Certify Consulting.
ISO 9001 isn't enough for medical devices. Learn why ISO 13485 is required, what's different, and how to choose the right standard. Expert guide by Jared Clark.
New articles are coming soon covering ISO 13485 implementation, FDA compliance strategy, and medical device quality management best practices. In the meantime, schedule a free consultation to discuss your specific QMS challenges.