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Biological Evaluation Procedure and Templates

We have developed high-quality Procedures and Templates /Forms for Medical Device Biological Evaluation procedures and templates in compliance with MDR. During the preparation of the Medical Device CE Marking Technical File, the Biological Evaluation Procedure and report with a conclusion must be attached especially for nonactive devices.

PMCF Plan Template

Biological Evaluation Procedure / SOP for preview

Type : Procedure
Title : Biological Evaluation Procedure
Document ID : I3C-BE-01/R1-04/20
Price : $150
Number of Downloads (until 12/2022) : 820

85 reviews

Biological Evaluation Report Templates preview

Type : Templates
Title : Biological Evaluation Plan
Document ID : I3C-TEM-66/R1-04/20
Price : $200
Number of Downloads (until 12/2022) : 640

67 reviews

Type : Templates
Title : Biological Evaluation Report
Document ID : I3C-TEM-67/R1-04/20
Price : $150
Number of Downloads (until 12/2022) : 820

120 reviews

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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.

Our service quality is primarily determined by the highly qualified professionals who work with us. We value our customers and respond to them when they have a need.



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.)


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.



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.


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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