Practical templates and guides for audit-ready execution
Explore checklists, SOP packs and document templates that align with any target market, including ISO 13485, MDSAP, FDA and EU MDR—built to save time and create clean evidence.
Audit-Ready Documents
Practical templates and guides you can deploy today to close gaps and standardize records across your QMS.
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Common questions about downloads
How do I receive the files?
After checkout you get an instant download link and a confirmation email with access instructions.
What formats are included?
Editable DOCX/XLSX/CSV and where applicable, PDF reference copies. Some kits include slide decks for training.
Can I customize these templates?
Yes—each document is meant to be tailored to your device, processes and market scope.
Do you provide updates?
Yes. Minor improvements and corrections are provided; you’ll receive an email with update notes and a fresh download link.
What about licensing?
Single-company license. You may use and modify internally, but redistribution or resale is not permitted.
Can you help me choose?
Absolutely. Book a quick call and we’ll match resources to your goals and timeline.
Not sure which template fits?
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