Clinical Evaluation Report SOP & Templates

I3CGLOBAL’s regulatory team has provided excellent support to the medical device community. Since September 2019, we have released their Clinical Evaluation Report SOP and templates, offering hundreds of firms ready-to-use, customized word files that can be purchased online. The templates are reasonably priced, offering great value for money, making them accessible to companies of all sizes.

The release of these templates couldn’t have come at a better time for companies preparing for the implementation of the MDR. According to the MDR article 10, all medical devices being sold or distributed in the European Union must comply with the new regulations by May 26, 2020, and it is a time-consuming process.

Overall, the release of these templates is a game-changer. It is a significant step towards simplifying the clinical evaluation reporting process and ensures that it is done efficiently and effectively. The regulatory team at I3CGLOBAL deserves commendation for their efforts in making these templates available first time to the medical device fraternity in 2019. With the availability of these templates, the regulatory team can now expedite their work and minimize compliance issues, leading to faster completion of tasks.

Is the templates follow EU 2017/745 requirements?

We are confident that the templates are of the highest quality and that they adhere to MDCG, MDR and the MEDDEV 2.7/1 Rev. 4 requirements.

What are the advantages of purchasing the procedures and templates?

The templates cover all aspects of clinical evaluation reports, including selecting and analyzing clinical data, assessing the state-of-the-art, and identifying clinical risks and benefits. By having access to these templates, companies can save a lot of time and effort in writing their reports. Instead of starting from scratch each time, they can utilize the templates to create their reports more efficiently.

Who is this template for?

These templates are not designed for the general public. This template is drafted for professionals such as PRRC, MR, QA, RA, subject experts and technical writers engaged in MDR /UKCA technical documentation inhouse without the need for consulting support.

What is included?

We have developed procedures for each activity involved in clinical evaluation, and corresponding templates have been created for each procedure. These documents and contents have been developed based on our extensive experience from multiple submissions to notified bodies for various classes of devices. They are presented in a format that has consistently obtained approval from Notified Bodies.

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.

Clinical Evaluation Report SOP/Procedure(s)

(Preview)

	95 reviews Number of Downloads (until 10/2022) : 532 Item : Clinical Evaluation Plan Procedure [I3C-CER-11] Number of pages : 04 Price : $300
	15 reviews Number of Downloads (untill 10/2022) : 32 Item : Procedure for Identification of Pertinent Data [I3C-CER-12] Number of pages : 03 Price : $150
	118 reviews Number of Downloads (untill 10/2022) : 560 Item : Procedure for Literature search and Review [I3C-CER-13] Number of pages : 05 Price : $350
	121 reviews Number of Downloads (untill 10/2022) : 397 Item: Procedure for the Appraisal of Clinical Data [I3C-CER-14] Number of pages : 06 Price : $150
	46 reviews Number of Downloads (untill 10/2022) : 231 Item: Demonstration of Equivalence Procedure [I3C-CER-15] Number of pages : 05 Price : $150
	96 reviews Number of Downloads (untill 10/2022) : 367 Item: Analysis of Clinical Data Procedure [I3C-CER-16] Number of pages : 05 Price : $150
	162 reviews Number of Downloads (untill 10/2022) : 846 Item: Development of Clinical Evaluation Report Procedure[I3C-CER-17] Number of pages : 09 Price : $250
	18 reviews Number of Downloads (untill 10/2022) : 111 Item: EN ISO 13485:2016 Clinical Evaluation Procedure [I3C-CER-18] Number of pages : 06 Price : $100

Clinical Evaluation Report Templates

(Preview)

	167 reviews Number of Downloads (untill 10/2022) : 532 Item: Clinical Evaluation Plan Template [I3C-TEM-11] Number of pages : 18 Price : $300
	121 reviews Number of Downloads (untill 10/2022) : 321 Item: Data Retrieved from Manufacturer Template [I3C-TEM-12] Number of pages : 25 Price : $50
	97 reviews Number of Downloads (untill 10/2022) : 470 Item: Literature Search and Review Plan Template [ I3C-TEM-13] Number of pages : 12 Price : $100
	88 reviews Number of Downloads (untill 10/2022) : 567 Item: Literature Search and Review Report Template [ I3C-TEM-14] Number of pages : 05 Price : $150
	15 reviews Number of Downloads (untill 10/2022) : 124 Item: Clinical Data Appraisal Plan Template [ I3C-TEM-15] Number of pages : 07 Price : $150
	14 reviews Number of Downloads (untill 10/2022) : 120 Item: Appraisal of Pertinent Data Template [I3C-TEM-16] Number of pages : 03 Price : $100
	27 reviews Number of Downloads (untill 10/2022) : 180 Item: Demonstration of Equivalence Template [ I3C-TEM-17] Number of pages : 10 Price : $100
	25 reviews Number of Downloads (untill 10/2022) : 320 Item: Analysis of Clinical Data Template [I3C-TEM-18] Number of pages : 09 Price : $100
	114 reviews Number of Downloads (untill 10/2022) : 650 Item: Clinical Evaluation Report Template [I3C-TEM-19] Number of pages : 20 Price : $450