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ISO 13485 Medical Device Auditing Service

2 January 2019 Comments are off

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SOP – IOP

19 April 2015 Comments are off

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cer clinical evaluation clinical evaluation mdr corsi nuovo regolamento dispositivi invasivi dispositivi non invasivi eudamed eudamed database mdr eudamed functional specifications eudamed mdr eudamed timeline eu mdr eu mdr human factors guidelines iec 60601-2 iec 62366-2 implant card requirements is eudamed active mdd mdr mdr classificazione mdr guidelines mdr news mdr vs mdd mdsap mdsap canada mdsap certification mdsap japan mdsap jurisdiction mdsap usa meddev MEDDEV 2.7.1 Rev 4 medical device medical device regulation medical device usability nuovo regolamento dispositivi medici pmcf pms post market surveillance reclassification regulatory affairs Riclassificazione dispositivi medici UDI usability engineering medical devices vigilanza

MDR Guidelines

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

Implementation Model for Medical Devices Regulation Step by Step Guide

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

TÜV SÜD – Fact Sheet

MHRA -MDR – IVDR Guidance

MDR Training Resources

- 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

- Regulation 745/2017 on Medical Devices: Unique Device Identification

- Regulation 745/2017 on Medical Devices: Technical File structure

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

Wordwide regulation resources

USA Regulatory Framework Medical Device registration
Taiwan Regulatory Framework Medical Device registration
South Korea Regulatory Framework Medical Device registration
South Africa Regulatory Framework Medical Device registration
Singapore Regulatory Framework Medical Device registration
Saudi Arabia Regulatory Framework Medical Device registration
Russia Regulatory Framework Medical Device registration
Peru Regulatory Framework Medical Device registration
New Zealand Regulatory Framework Medical Device registration
Mexico Regulatory Framework Medical Device registration
Malaysia Regulatory Framework Medical Device registration
Japan Regulatory Framework Medical Device registration
India Regulatory Framework Medical Device registration
Hong Kong Regulatory Framework Medical Device registration

Recent Posts

Importance of CEP/CER, PSUR, PMCF in the Regulatory Compliance of Medical Devices
Decentralized clinical trials (DCTs) with Medicinal Products in Switzerland – Position Paper
Medical Devices – US FDA Regulations Versus EU MDR
ISO 11608 – Testing Protocols for Needle Based Injection Systems (NISs)
The UKCA Marking – Access the UK Market

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Medical Device Development
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Reverse Engineering – Laser Scanning
- 3D Tomography Analysis

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ISO 13485 Auditing Service
ISO 14971 Gap Analysis
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Design Control Process
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ISO 14971:2012 – 2019 Gap Analysis

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

Medical Device Development
Design & Engineering
Pre-series and Prototype
Finite Element Analysis
Mechanical Design
Reverse Engineering – Laser Scanning
- 3D Tomography Analysis

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ISO 13485 Medical Device Auditing Service

ISO 13485 Medical Device Auditing Service

ISO 13485 Medical Device Auditing Service

ISO 13485 Medical Device Auditing Service

ISO 13485 Medical Device Auditing Service

ISO 13485 Medical Device Auditing Service

ISO 13485 Medical Device Auditing Service

ISO 13485 Medical Device Auditing Service

Quality System Support
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
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
Biological Safety Evaluation
Cardiovascular Digital Simulation Model
ISO 10993-17 Toxicological Evaluation
Test Mascherine Chirurgiche e FFP2, FFP3 – Coronavirus

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