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19 April 2015 Comments are off

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Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations

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Fact Sheet for Manufacturers of Medical Devices

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide

Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices

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- Regulation 745/2017 on Medical Devices: main changes and timeline to implementation

- Regulation 745/2017 on Medical Devices: obligations of the economic operators, from Eudamed registration to Responsible person

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- Regulation 745/2017 on Medical Devices: Post Market activities and follow up

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- 3D Tomography Analysis

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Mechanical Test Fatigue Static

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Mechanical Test Fatigue Static

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ISO 13485 Auditing Service
ISO 14971 Gap Analysis
MDSAP – Medical Device Single Audit Program
SOP – IOP
VMP IQ/OQ/PQ Validation
Clean Room Design and Validation

MDR Consulting Service
EU Authorized Representative Service
CH-REP – SAR Swiss Authorized Representative service
EU PRRC
Design Control Process
DHF Design History File
Technical File Design Dossier
Risk Management Process
Clinical Evaluation
ISO 14971:2012 – 2019 Gap Analysis

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Mechanical Test Fatigue Static
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Cardiovascular Digital Simulation Model
ISO 10993-17 Toxicological Evaluation
Test Mascherine Chirurgiche e FFP2, FFP3 – Coronavirus

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