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Everything you need to build a compliant medical device quality system, ready to tailor. A Quality Manual, twelve core procedures, and all six MEDEVEX toolkits — the whole system in one download, drawn from the way MEDEVEX builds and remediates quality systems in industry.
Quality Manual template with a full ISO 13485 clause-to-procedure map.
Twelve tailorable procedures (SOPs): document & records control, management review, training, internal audit, supplier control, risk management, design control, design transfer & process validation, CAPA, nonconformance, and complaint handling.
All six MEDEVEX toolkits (workbooks + templates): ISO 14971 Risk, QMS Audit & CAPA, Design Controls, Design Transfer, Program Management, and Portfolio & Resource.
A Contents & Implementation Roadmap that walks you through standing up the system, plus tailoring guides for each area.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD startups and scale-ups building or overhauling a quality system, and quality/regulatory leaders who want a complete, consistent, inspection-ready foundation instead of assembling it piece by piece.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.Everything you need to build a compliant medical device quality system, ready to tailor. A Quality Manual, twelve core procedures, and all six MEDEVEX toolkits — the whole system in one download, drawn from the way MEDEVEX builds and remediates quality systems in industry.
Quality Manual template with a full ISO 13485 clause-to-procedure map.
Twelve tailorable procedures (SOPs): document & records control, management review, training, internal audit, supplier control, risk management, design control, design transfer & process validation, CAPA, nonconformance, and complaint handling.
All six MEDEVEX toolkits (workbooks + templates): ISO 14971 Risk, QMS Audit & CAPA, Design Controls, Design Transfer, Program Management, and Portfolio & Resource.
A Contents & Implementation Roadmap that walks you through standing up the system, plus tailoring guides for each area.
Single-organization license; edit and co-brand for internal use.
Medical device and IVD startups and scale-ups building or overhauling a quality system, and quality/regulatory leaders who want a complete, consistent, inspection-ready foundation instead of assembling it piece by piece.
Instant download · Excel + Word files you can edit and co-brand · single-organization license · lifetime access to this version.
Because this is an instant digital download, all sales are final and non-refundable. If a file won’t download or appears corrupted, email aaron.vant@medevexconsulting.com and we’ll make it right. Single-organization license; not for resale or redistribution.