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What is a Regulatory Change- and Impact Analysis?
ColabON's Regulatory Change and Impact Analysis Accelerates and Improves Compliance Assessment Regulatory Change- and Impact Analysis...
Feb 17
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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
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How to optimize the process for Product Labeling for Medical Devices?
Product Labeling for Medical Devices is an essential part of the certification process and the technical documentation. It involves...
Nov 24, 2024
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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
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Medical Devices and IVDs: Your Cookbook for the List of Applicable Standards, Regulations & Guidelines
International Standards Medical Devices Links and Tipps
Nov 9, 2024
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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
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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
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Current List of EU-MDR - IVDR Harmonized Standards Medical Devices
#harmonisedstandardsmedicaldevices #harmonizedstandardsmedicaldevices
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Mar 19, 2024
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