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.

Is the templates follow MDR and ISO 14971 requirements?

Yes, the templates are made as per current requirements.

What are the advantages of purchasing the procedures and templates?

The procedure and template fully adhere to the necessary requirements of ISO 14971. By purchasing the ready-to-use Word files, companies can save valuable time spent on comprehension and editing, enabling them to submit reports with greater efficiency.

Who is this template for?

These templates are not designed for the general public. This template is drafted for professionals working in R&D, Desig and Development, QA, RA, and technical experts engaged in any regulatory documentation or MDR technical documentation.

What is included?

Procedure and record template included, made specific to each activity as per ISO 14971:2019 including Risk Management Plans, Files, Reports, PHA, FMEA, risk acceptability, risk estimation, risk control, overall residual risk, benefit risk analysis and post-production information.

What is the file type? Are there any limitations on use?

All documents are made in Microsoft word. No limitation on use.

Refund Policy

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

How can I receive the sales invoice /bill??

The purchased softcopy document will be accompanied by an attached copy of the invoice. The invoice will be from PayPal, and there will be no separate or alternative invoice provided.

How can I obtain the purchased files and documents?

The files you purchased are NOT instantly downloaded.

However, within 1-5 hours of receiving the payment confirmation (excluding Sundays as they are holidays), you will receive an email. Please ensure to check the email address provided during the purchase process.

The email will contain a DROPBOX link through which you can access and download the purchased files or documents.

Risk Management File (RMF) Procedure / SOP

117 reviews

Number of Downloads (untill 10/2022) : 890

Item: Risk Management [I3C-RMF-01]
Number of pages : 09

Price : $200

117 reviews

Number of Downloads (untill 10/2022) : 220

Item: Benefit Risk Analysis [I3C-UEF-01]
Number of pages : 09

Price : $150

Risk Management File (RMF) Forms / Templates

	37 reviews Number of Downloads (untill 10/2022) : 347 Item: Risk Management File [I3C-TEM-50] Number of pages : 09 Price : $350
	28 reviews Number of Downloads (untill 10/2022) : 59 Item: Annex A Identification of Medical Device Characteristics [I3C-TEM-51] Number of pages : 09 Price : $50
	25 reviews Number of Downloads (untill 10/2022) : 320 Item: Annex B Risk Management Plan [I3C-TEM-52] Number of pages : 09 Price : $150
	162 reviews Number of Downloads (untill 10/2022) : 320 Item: Annex C Risk Management Process [I3C-TEM-53] Number of pages : 09 Price : $100
	58 reviews Number of Downloads (untill 10/2022) : 580 Item: Annex D Risk Management Report [I3C-TEM-54] Number of pages : 09 Price : $200
	Coming Soon Number of Downloads (untill 10/2022) : Coming Soon Item: Benefit Risk Assessment [I3C-TEM-55] Number of pages : 09 Price : $250