Maven
Technical File Templates

Technical File Templates

Regulatory and QMS Technical File Templates

Looking for technical templates online? Or Have in-house capabilities to prepare documentation but need assistance only for some specific documents? Or need assistance only specific to documents that have been updated in EU MDR? Looking to adapt MDQMS, MDSAP, and 21CFR Part 820?

Maven provides standard document templates that will help you create and maintain documents compliant to various standards and regulations.

Based on years of experience of preparing, reviewing and complying with the requirements of regulations, and working closely on review comments received by various notified bodies and understanding their auditing trends our in-house experts have curated these templates for easy preparation and adaptation in your organization.

These templates have been differentiated into “Regulatory” and “QMS” for your ease of search. You will be able to find all relevant templates individually and some in bunch at a discounted price if bought together. Please do note however, these templates are made solely based on our experience in the field for more than a decade and our interpretation of guidelines and standards and can always have minor findings from 3rd person perspective on further review.

Click on the links below, add the templates to your cart and purchase and we shall share the templates on the registered Email ID after we receive your payment during the working hours. In case of any delays, you can always write back to us on enquiry@mavenprofserv.com.

For Indian clients: Kindly write to us on enquiry@mavenprofserv.com with the details of the template you wish to purchase and we shall assist you in making the purchase.

What are you waiting for? Buy the templates and start customizing!

  • Regulatory
  • QMS

Sets of documents


Risk Management file

Price: $1450 $1160 (20% off)

  • Risk Management Policy
  • Risk Management Plan
  • FMEA Table
  • Risk Management Report

Pre-clinical testing

Price: $1700 $1360 (20% off)

  • Biological Evaluation Plan
  • Biological Evaluation Report
  • Biological Safety Risk Assessment
  • Identification of applicable biocompatible tests
  • Summary of pre-clinical testing

Clinical Evaluation file

Price: $3000 $2400 (20% off)

  • Clinical Evaluation Plan
  • Literature Search Protocol (LSP)
  • Literature Appraisal
  • Literature Search Report (LSR)
  • Demonstration of Equivalence
  • Vigilance Data
  • Clinical Evaluation Report

Usability Engineering file

Price: $900 $720 (20% off)

  • Usability Engineering Plan
  • Usability Engineering Report


Post Market Surveillance (PMS)

Price: $1600 $1280 (20% off)

  • Post Market Surveillance (PMS) Plan
  • Post Market Surveillance Report (PMSR)
  • Periodic Safety Update Report (PSUR)

Individual documents

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