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For organizations starting out. Initiates the minimum necessary procedures of an ISO 13485-compliant Quality Management System (QMS) to get your development going. Includes 1-2 Hours of consulting start-up support and training.
Starter QMS Package includes:
Quality Manual
Document Controls SOP
Design Controls SOP
Risk Management SOP
Requirements Templates
Project Planning Templates
FMEA Templates
For organizations starting out. Initiates the minimum necessary procedures of an ISO 13485-compliant Quality Management System (QMS) to get your development going. Includes 1-2 Hours of consulting start-up support and training.
Starter QMS Package includes:
Quality Manual
Document Controls SOP
Design Controls SOP
Risk Management SOP
Requirements Templates
Project Planning Templates
FMEA Templates
