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About Simplimedica
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Software as a Medical Device
EU Medical Devices Regulation
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Medical Device Auditing
Process Equipment Validation
Quality Management for Medical Devices
Digital Healthcare
Clinical Evaluation Services
Med-Tech Start-Ups
Validation
Quality Management System
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Templates
Equipment Validation
Medical Devices
Pharmaceuticals
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About Simplimedica
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PRRC & Authorised Rep
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Regulations for Med-Tech Start Up
Software as a Medical Device
EU Medical Devices Regulation
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Medical Device Auditing
Process Equipment Validation
Quality Management for Medical Devices
Digital Healthcare
Clinical Evaluation Services
Med-Tech Start-Ups
Validation
Quality Management System
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MDR & IVDR
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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
26 June 2025
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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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Economic Operators Gap Assessment
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Economic Operators Gap Assessment
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10 May 2019
26 June 2025
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Guidance for EU MDR – Systems and Procedure Packs
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Guidance for EU MDR – Systems and Procedure Packs
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14 May 2019
26 June 2025
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Guidance for EU MDR 2017/745 – Reusable Medical Devices (Class Ir)
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Guidance for EU MDR 2017/745 – Reusable Medical Devices (Class Ir)
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11 December 2019
26 June 2025
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Guidance for EU MDR 2017/745 – Drug-Device combination products
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Guidance for EU MDR 2017/745 – Drug-Device combination products
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10 November 2019
26 June 2025
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Guidance for EU MDR Software as a Medical Device (SaMD)
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Guidance for EU MDR Software as a Medical Device (SaMD)
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13 May 2019
26 June 2025
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Guidance for Unique Device Identifier (UDI)
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Guidance for Unique Device Identifier (UDI)
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10 May 2019
26 June 2025
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MDR Complete Package
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MDR Complete Package
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13 May 2019
26 June 2025
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Periodic Survey Update Template
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Periodic Survey Update Template
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10 May 2019
26 June 2025
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