Quality Systems

Document NGS bioinformatics pipeline changes, assess validation impact, control software and database updates, and prepare IEC 62304 audit records for IVDs.

Draft QMSR supplier quality agreements for cloud, AI, cybersecurity, testing, and sterilization vendors with audit, CAPA, change notice, and evidence clauses.

Operational guide to converting RUO assays into regulated IVDs, covering claims cleanup, distributor controls, data triage, validation bridging, training, and evidence firewalls.

Track 2026 UDI compliance deadlines across the EU, Switzerland, Australia, China, Brazil, Singapore, and the US, with class rules and data requirements.

Guide to 12 common FDA cybersecurity premarket deficiencies in 2026, including SBOM, threat modeling, risk assessment, Section 524B, guidance alignment, and practical fixes.

Build cleaning validation protocols for reusable surgical instruments, covering test soils, residue endpoints, worst-case devices, ST98 criteria, sampling, and reports.

Downloadable EU MDR GSPR checklist template for Annex I evidence mapping, applicability, standards, gap analysis, ownership, and remediation tracking.

Guide to ISO 17664 reprocessing validation for reusable devices, covering cleaning, disinfection, sterilization, worst-case families, IFU content, FDA expectations, and submission evidence.

Protocol-level guide to IVD analytical validation, covering LoD, LoQ, precision, interference, cross-reactivity, stability, CLSI methods, and FDA/IVDR evidence.

Use this EU MDR PMCF plan template to define objectives, methods, endpoints, timelines, reports, PMS integration, and MDCG 2020-7 traceability.

Regulatory strategy for pre-filled syringes and auto-injectors, covering FDA OCP/RFD, ISO 11608, human factors, EU MDR Article 117, QMSR, stability, and lifecycle changes.

Step-by-step guide to writing validated reprocessing instructions for reusable device IFUs, covering cleaning, sterilization, usability, warnings, and audits.

Use this supplier audit checklist for ISO 13485 and FDA QMSR compliance, covering supplier risk, qualification, audit agendas, quality agreements, CAPA follow-up, and records.

Validate washer-disinfector equipment and cycles under ISO 15883, including IQ/OQ/PQ, A0 thermal disinfection, load configurations and routine monitoring.

Understand Health Canada's 2026 device reforms, including Terms and Conditions powers, AI/ML guidance, REP, IMDRF ToC, significant changes, and market access actions.

Guide to FDA's February 2026 premarket cybersecurity guidance update for QMSR and ISO 13485 alignment, including what changed, what stayed, mapping, and connected device steps.

Analyze 2024-2026 medical device recall trends, including Class I increases, device failure causes, software defects, FDA alerts, affected units, and risk mitigation.

Manage third-party cybersecurity risk for connected medical devices using FDA Section 524B, QMSR and ISO 13485 controls, SBOMs, vendor assessments, and threat modeling.

Prepare for the 2026 RAPS RAC exam with guidance on RAC-Devices vs RAC-Drugs, eligibility, exam content, testing windows, study resources, and career impact.

How to choose Agile, Waterfall, or hybrid medical device software development under IEC 62304, with AAMI TIR45 mapping, design controls, and auditor evidence expectations.