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!
Risk Management file
Price: $1450 $1160 (20% off)
Pre-clinical testing
Price: $1700 $1360 (20% off)
Clinical Evaluation file
Price: $3000 $2400 (20% off)
Usability Engineering file
Price: $900 $720 (20% off)
Post Market Surveillance (PMS)
Price: $1600 $1280 (20% off)
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
