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ISO 14971

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PMCF Plan Template

Risk Analysis Template & Procedure

We have developed a Medical Device ISO 14971 Risk Analysis Procedures and Template in line with MDR & IVDR. During the preparation of Medical Device CE Marking Technical File, Risk-Benefit Analysis is an integral part of compliance documentation along with supporting documents and final risk conclusions.

PMCF Plan Template

Risk Management File (RMF) Procedure / SOP

Type : Procedure
Title : Risk Management
Number of Pages : 09
Price : $200
Number of Downloads (until 10/2022) : 890

rating
117 reviews

Type : Procedure
Title : Benefit Risk Analysis
Number of Pages : 09
Price : $150

Coming soon…


117 reviews

Risk Management File (RMF) Forms / Templates

Type : Template
Title : Risk Management File
Number of Pages : 09
Price : $350
Number of Downloads (until 10/2022) : 347


37 reviews

Type : Template
Title : Annex A Identification of Medical Device Characteristics
Number of Pages : 09
Price : $50
Number of Downloads (until 10/2022) : 59


28 reviews

Type : Template
Title : Annex B Risk Management Plan
Number of Pages : 09
Price : $150
Number of Downloads (until 10/2022) : 320


25 reviews

Type : Template
Title : Annex C Risk Management Process
Number of Pages : 09
Price : $100
Number of Downloads (until 10/2022) : 320


162 reviews

Type : Template
Title : Annex D Risk Management Report
Number of Pages : 09
Price : $200
Number of Downloads (until 10/2022) : 580


58 reviews

Type : Template
Title : Benefit Risk Assessment
DNumber of Pages : 09
Price : $250

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We have been in the regulatory consulting business since 1999. After two decades, we have grown to be one of the largest groups, with offices in more than six countries. More than 2000 companies are connected to us in some way and will always be with us in the coming years.

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TERMS OF PURCHASE

Delivery

The files you purchased are not downloaded automatically. After obtaining payment confirmation, you will receive an email within 1-6 hours. (Sundays are days off.)

Disclaimer

Our technical experts create the softcopy procedures, templates, and checklists for sale after interpreting and debating guidelines. The briefings or explanations given in each section do not constitute an official or signed contract, and no grievances will be considered. Buyers should keep in mind that the writers are human beings, and there might be a few flaws as interpreted by regulatory authorities or other professional experts in this area.

Refund Policy

We will NOT issue a refund once the softcopy document has been submitted.

ADDITIONAL PURCHASE INFORMATION

Guarantee

Softcopy procedures, forms, and checklists for sale must be updated and filled out according to the scope of the product. We cannot guarantee that simple forms will be accepted by the NB or FDA, but properly filled forms based on our advice will have a better chance of being accepted.

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Along with the purchased softcopy document, a copy of the invoice will be attached. PayPal will produce the invoice. There will be no different invoice.

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DOCUMENTS ARE UNDER REVISION AS PER COMMENTS FROM VARIOUS WELWISHERS AND AUTHORITIES