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 business@mavenprofserv.com.

For Indian clients: Kindly write to us on business@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
  • Risk Management Team
  •  
  •  




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

Device Description & Specification

Price: $200





Classification Report

Price: $150





Similar Device Report

Price: $300





Checklist for Artwork

Price: $100





Checklist for Instructions for Use (IFU)

Price: $100





Implant Card

Price: $200





Implant Card Leaflet

Price: $200





General Safety & Performance Requirements (GSPR)

Price: $350





Risk Management Policy

Price: $100





Risk Management Plan

Price: $200





FMEA Table

Price: $500





Risk Management Report

Price: $600





Risk Management Team

Price: $50





Biological Evaluation Plan

Price: $600





Biological Evaluation Report

Price: $250





Biological Safety Risk Assessment

Price: $750





Identification of applicable biocompatible tests

Price: $100





Post Market Clinical Follow-up (PMCF) Plan

Price: $500





Post Market Clinical Follow-up (PMCF) Report

Price: $600





Clinical Evaluation Plan

Price: $1000





Literature Search Protocol (LSP)

Price: $300





Literature Appraisal

Price: $300





Literature Search Report (LSR)

Price: $200





Demonstration of Equivalence

Price: $100





Vigilance Data

Price: $100





Clinical Evaluation Report

Price: $1000





Usability Engineering Plan (Both UOUP and S+F)

Price: $400





Usability Engineering Report (Both UOUP and S+F)

Price: $500





SSCP (Summary of Safety and Clinical Performance)

Price: $600





Declarations – Pack of all

Price: $100





Post Market Surveillance (PMS) Plan

Price: $500





Post Market Surveillance Report (PMSR)

Price: $500





Periodic Safety Update Report (PSUR)

Price: $600





Checklist – Company Profile

Price: $50





Declaration of Conformity

Price: $100





Summarized TCF

Price: $200





Person Responsible for Regulatory Compliance (PRRC) – appointment letter

Price: $50





Accelerated stability study protocol

Price: $200





Accelerated stability study report

Price: $200





Real-time stability study protocol

Price: $200





Real-time stability study Report

Price: $200





Design file

Price: $650





ETO Validation (Over-Kill Approach)

Price: $650





Gamma Sterilization Validation

Price: $650





Steam sterilization Validation

Price: $500





Packaging Validation

Price: $350





Transportation Validation

Price: $250





Injection Molding Validation

Price: $150





Bio-Burden Method Validation

Price: $300





Ultrasonic Cleaning

Price: $150





Electropolishing Validation

Price: $150





Anodizing Validation

Price: $150





Approved Supplier List

Price: $20





Supplier Agreements

Price: $50





Distributor agreements

Price: $50





Incoming Inspection/ Quality Plan

Price: $150





In-process Inspection/ Quality Plan

Price: $150





Final Inspection/ Quality Plan

Price: $150





Sampling Plan – variants based diff methods

Price: $150





Quality Manual

Price: $200





All quality procedures and formats as required by ISO 13485

Price: $600





All quality procedures and formats as required by ISO 13485 and 21 CFR Part 820

Price: $650





All quality procedures and formats as required by MDSAP

Price: $700





Regulatory Strategy

Price: $150





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