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About
About Simplimedica
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Regulatory Services
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PRRC & Authorised Rep
Training Courses
Clinical Evaluation & Investigation
Design Control and Risk Management
Regulations for Med-Tech Start Up
Software as a Medical Device
EU Medical Devices Regulation
EU IVDR Training Course
Medical Device Auditing
Process Equipment Validation
Quality Management for Medical Devices
Digital Healthcare
Clinical Evaluation Services
Med-Tech Start-Ups
Validation
Quality Management System
Shop
Book Consultation
Templates
Equipment Validation
Medical Devices
Pharmaceuticals
Insights
News
Simplimedica Podcasts
Resources
Intended Use Statement
Medical Devices Regulatory Insights
Contact
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About
About Simplimedica
Internships
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Regulatory Services
Quality and Compliance
Consultant on Demand
PRRC & Authorised Rep
Training Courses
Clinical Evaluation & Investigation
Design Control and Risk Management
Regulations for Med-Tech Start Up
Software as a Medical Device
EU Medical Devices Regulation
EU IVDR Training Course
Medical Device Auditing
Process Equipment Validation
Quality Management for Medical Devices
Digital Healthcare
Clinical Evaluation Services
Med-Tech Start-Ups
Validation
Quality Management System
Shop
Book Consultation
Templates
Equipment Validation
Medical Devices
Pharmaceuticals
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medical device templates
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21 April 2018
26 June 2025
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Biological Evaluation Report
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Biological Evaluation Report
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21 April 2018
26 June 2025
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CE Technical File
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CE Technical File
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13 May 2019
26 June 2025
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Clinical Evaluation Guidance Document
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Clinical Evaluation Guidance Document
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31 August 2019
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Clinical Evaluation Template
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Clinical Evaluation Template
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26 June 2025
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Design and Development Plan
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Design and Development Plan
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22 April 2018
26 June 2025
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Design Inputs
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Design Inputs
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Design Traceability Matrix
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Design Traceability Matrix
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Design Transfer Plan
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Design Transfer Protocol
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Design Transfer Protocol
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24 April 2018
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Design Validation Protocol
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Design Validation Protocol
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21 April 2018
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Design Validation Report
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24 April 2018
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Design Verification Report
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Design Verification Report
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22 April 2018
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