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Current List of Harmonized Standards under the EU-IVDR (In Vitro Diagnostic Devices)
This overview presents the currently harmonized and relevant standards for in vitro diagnostic devices (IVDs) under the European Regulation (EU) 2017/746 (IVDR). Harmonized standards bridge the gap between legal requirements and technical implementation. They help demonstrate the state of the art and simplify the process of proving conformity with the IVDR. All official Publications of EU-IVDR Harmonized Standards for invitro diagnostic devices (IVDs) Current Status: 08.04.2
Nov 12
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
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
3 Steps: List of Standards and Regulations for Medical Devices
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
International Standards Medical Devices Links and Tipps
Nov 9, 2024
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?
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
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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