ISO 13485 Medical Device QMS Starter
Quality manual, 10 core procedures, DHF/DMR/DHR templates, ISO 14971-style risk file, CAPA and complaint logs.
What's inside →$147Buy now
Medical quality kits
Quality system, risk, design controls, validation, complaints, cleanroom and EU MDR templates for small medical device makers and contract manufacturers. All files are templates, not regulatory advice or certification.
18 kits · instant download · editable Word & Excel
FDA QMSR Transition Kit (21 CFR 820)
Gap assessment mapping the old QSR to the QMSR / ISO 13485, a records matrix and a transition plan. Templates, not regulatory advice.
What's inside →$67Buy now
ISO 14971 Risk Management Kit
Risk plan, hazard analysis tied to an editable acceptability matrix, FMEA, benefit-risk and the risk management report. Templates, not regulatory advice.
What's inside →$57Buy now
Design Controls Kit
Traceability matrix with gap flags, design plan, design review, V&V protocol/report and design transfer templates. Templates, not regulatory advice.
What's inside →$77Buy now
Process Validation IQ/OQ/PQ Kit
Master validation plan, IQ/OQ/PQ protocols and reports, and a sample-size and Ppk calculator. Templates, not regulatory advice.
What's inside →$57Buy now
Complaint Handling & MDR Kit
Intake and investigation forms, 21 CFR 803 reportability decision tree, complaint log with due dates and trending. Templates, not regulatory advice.
What's inside →$47Buy now
Cleanroom Monitoring Kit (ISO 14644)
Monitoring log with alert/action flags, gowning qualification, cleaning record and excursion form. Templates, not regulatory advice.
What's inside →$47Buy now
EU MDR Technical File Starter
Technical documentation index, GSPR checklist structure, PMS data log, PMS plan and PSUR templates. Templates, not regulatory advice.
What's inside →$77Buy now
Biocompatibility Planning Kit (ISO 10993)
Endpoint matrix with gap flags, device categorization, materials inventory, biological evaluation plan and report shell. Templates, not regulatory advice.
What's inside →$57Buy now
Sterilization Validation Kit (EO / Steam / Radiation)
Validation tracker for EO, steam and radiation, requalification calendar, BI and dose release log, protocol and report. Templates, not regulatory advice.
What's inside →$67Buy now
Medical Device Software Kit (IEC 62304)
Lifecycle checklist, requirements-to-test traceability, SOUP register, problem reports, SDP and release checklist. Templates, not regulatory advice.
What's inside →$67Buy now
Usability Engineering Kit (IEC 62366-1)
Use specification, use-related risk analysis with critical-task flags, formative/summative test log and HFE summary. Templates, not regulatory advice.
What's inside →$57Buy now
Med Device Supplier Quality Kit
Risk-based approved supplier list with audit-due flags, scorecard, SCAR log, quality agreement and procedure. Templates, not regulatory advice.
What's inside →$47Buy now
MDSAP Audit Prep Kit
Readiness tracker for the 7 MDSAP audit processes, 5-jurisdiction checklist, NC grading worksheet and audit plan. Templates, not regulatory advice.
What's inside →$57Buy now
UDI & Labeling Kit
UDI-DI register with GUDID/EUDAMED flags, US and EU label review checklist, label change form and procedure. Templates, not regulatory advice.
What's inside →$47Buy now
Medical Device Cybersecurity Documentation Kit (FD&C Act 524B)
Threat model, exploitability-based risk assessment, SBOM inventory, vulnerability log and submission checklist. Not regulatory advice.
What's inside →$77Buy now
ISO 11607 Sterile Packaging Validation Kit
Packaging gap tracker by ISO 11607-1/-2 clause, seal-strength workbook with Ppk, accelerated-aging calculator, validation master plan, sealer IQ/OQ/PQ protocol and distribution/aging test plan. Templates, not regulatory advice.
What's inside →$77Buy now
Medical Complete Bundle v2: 15 medical device quality kits (ISO 13485, FDA QMSR, ISO 14971, IEC 62304, MDSAP and more)
Not eligible for NQT documentation review (all kits in this bundle). 15 medical device quality kits in one download of editable Word and Excel templates for small device makers and contract manufacturers. $975 if bought separately: save $678.
What's inside →$297Buy now
NQT Pro Medical Coming soon
Every medical kit, new medical templates each month, a plain-English regulatory watch note (FDA QMSR, EU MDR) and a monthly live Q&A. Planned at $29/month or $249/year. Templates and education, not regulatory advice. Grab the free checklist to hear when it opens.