Menu

Design & Engineering
Quality & Validation
Regulatory Support
Testing
Electronic IFU (e-IFU)

No products in the cart.

You are here:

Home
quality system gap analysis

quality system gap analysis

ISO 13485 Medical Device Auditing Service

2 January 2019 Comments are off

More
Quality System Support

19 April 2015 Comments are off

More

Tags

3D printing applying human factors and usability engineering to optimize medical device design cer clinical evaluation clinical evaluation mdr corsi nuovo regolamento dispositivi invasivi dispositivi non invasivi eudamed 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 usa meddev MEDDEV 2.7.1 Rev 4 medical device medical device regulation medical device regulations Medical Devices 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

The Future of Validation and Verification in Medical Device Manufacturing
Medical Devices in Europe – Key Trends Shaping the Future Industry
Gap Analysis for EUDAMED Compliance
Importance of CEP/CER, PSUR, PMCF in the Regulatory Compliance of Medical Devices
Decentralized clinical trials (DCTs) with Medicinal Products in Switzerland – Position Paper

Reach out to us today!

Name (required)

Email (required)

Message (required)

9 + 15 ? (Are you human?)

Subscribe to our Newsletter

Stay tuned

Your Email

About Us
Ask a Quote
For Freelances
Work with Us
Trainings
Service List
We Are ISO 13485 Certified
MDR Consulting
Q&R Blog

English

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

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

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

Some of our Clients

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

Meet us at

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

Subscribe to our Newsletter

Email Address

Design & Engineering
Quality & Validation
Regulatory Support
Testing
Electronic IFU (e-IFU)

TS Quality & Engineering

Back to Top