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Change History: MDR Medical Device Regulation EU 2017/745

Change History: MDR Medical Device Regulation EU 2017/745

Change History: MDR Medical Device Regulation EU 2017/745

Overview of the current changes to the Medical Device Regulation (MDR). We collected all helpful data within the ColabON tool. This involved

Jan 17

ColabON's Roles and Responsibility for Quality Management System are designed for organizational changes. They are a content element, than can be used in processes. This helps not only for re-organizations, but also to understand trainings needs.

ColabON's Roles and Responsibility for Quality Management System are designed for organizational changes. They are a content element, than can be used in processes. This helps not only for re-organizations, but also to understand trainings needs.

How to define Roles and Responsibility for Quality Management System: Once and for all

Roles and Responsibility: A role is a function of a person.

Nov 27, 2024

List of Standards and Regulations for Medical Devices

List of Standards and Regulations for Medical Devices

How to generate a "List of Standards and Regulations" for Medical Devices: 3 Steps supporting registration and development

Strategy to select the essential standards and regulations supporting both, development and registration.

Nov 15, 2024

Medical Devices and IVDs: Your Cookbook for the List of Applicable Standards, Regulations & Guidelines

Medical Devices and IVDs: Your Cookbook for the List of Applicable Standards, Regulations & Guidelines

Medical Devices and IVDs: Your Cookbook for the List of Applicable Standards, Regulations & Guidelines

International Standards Medical Devices Links and Tipps

Nov 9, 2024

Understanding SN EN ISO 13485/A11 2021 and its role in medical device compliance

Understanding SN EN ISO 13485/A11 2021 and its role in medical device compliance

Understanding SN EN ISO 13485/A11 2021 and its role in medical device compliance

SN EN ISO 13485/A11:2021 Medical devices — Quality management systems — Requirements for regulatory purposes Amendment 11 SN EN ISO...

Sep 30, 2024

How do I handle changes in regulatory requirements for medical devices?

How do I handle changes in regulatory requirements for medical devices?

How do I handle changes in regulatory requirements for medical devices?

Regulatory Requirements for Medical Devices Regulatory requirements for medical devices include all legal, normative, and governmental...

Sep 6, 2024

The Hidden Risks of Poor Data Quality: Low Degree of Digitization in Medical Device Industry

The Hidden Risks of Poor Data Quality: Low Degree of Digitization in Medical Device Industry

The Hidden Risks of Poor Data Quality: Low Degree of Digitization in Medical Device Industry

Poor Data Quality lead to High time loss for experts in norm interpretation Very high costs for maintaining traceability High compliance...

Aug 16, 2024

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