TEMPLATES
We have a selection of free and premium templates available ranging from checklists to hazard traceability matrixes. Though we are currently unable to custom-make templates upon request, we are continuously adding to our templates.
Free Templates
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Design and Development Plan Template (Medical Device per ISO 13485 and 21 CFR 820) Free
0 € (ex. GST/VAT) -
Risk Analysis/Hazard Traceability Matrix Template Free
0 € (ex. GST/VAT) -
Risk Management Plan Template (Medical Device and ISO 14971) Free
0 € (ex. GST/VAT) -
Status Report Template (Full) Free
0 € (ex. GST/VAT) -
Checklist ISO 14971:2007 to ISO 14971:2019 Free
0 € (ex. GST/VAT)
Premium Templates
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Project Charter Template
29 € (ex. GST/VAT) -
Standard Operating Procedure (SOP) for Risk Management according to EN ISO 14971:2019
99 € (ex. GST/VAT) -
Software Safety Classification Template
49 € (ex. GST/VAT) -
Use specification Template
99 € (ex. GST/VAT) -
Design Review Record Template
49 € (ex. GST/VAT) -
Standard Search Report Template
49 € (ex. GST/VAT)
Would you like to learn more about risk management or design control?
Take a look at our Introduction to Risk Management for Medical Devices and ISO 14971 online course and Introduction to Design Control for Medical Devices online course. These courses are taken by competent authorities, notified bodies and medical device manufacturers and distributors. Certification on successful completion of course.
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