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ISO 14971

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RISK ANALYSIS PROCEDURE

Risk Analysis Procedure and Templates

We have developed a Medical Device ISO 14971 Risk Analysis Procedures 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, Design 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.

PMCF Plan Template

Risk Analysis Procedure / RMF Procedure / SOP

rating
117 reviews

Number of Downloads (untill 10/2022) : 890

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

Price : $200

rating2
117 reviews

Number of Downloads (untill 10/2022) : 220

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

Price : $150

Risk Analysis report writing Forms / Templates

rating2
37 reviews

Number of Downloads (untill 10/2022) : 347

Item: Risk Management File [I3C-TEM-50]
Number of pages : 09

Price : $350

rating3
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

rating2
25 reviews

Number of Downloads (untill 10/2022) : 320

Item: Annex B Risk Management Plan [I3C-TEM-52]
Number of pages : 09

Price : $150

rating2
162 reviews

Number of Downloads (untill 10/2022) : 320

Item: Annex C Risk Management Process [I3C-TEM-53]
Number of pages : 09

Price : $100

rating4
58 reviews

Number of Downloads (untill 10/2022) : 580

Item: Annex D Risk Management Report [I3C-TEM-54]
Number of pages : 09

Price : $200

rating3
Coming Soon

Number of Downloads (untill 10/2022) : Coming Soon

Item: Benefit Risk Assessment [I3C-TEM-55]
Number of pages : 09

Price : $250