Tag Archives: medical device regulations

Gap Analysis for EUDAMED Compliance

30 March 2023 0 Comments

Gap analysis is a crucial step for any company seeking EU EUDAMED compliance, as it serves to identify the differences between the company’s current operations and the new regulation. With realizing EUDAMED, manufacturers of medical devices will be required to comply with new regulations and requirements that will have an impact on their operations and […]
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Quality & Regulatory Blog

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EU IVDR
eu mdr
EU Regulations
eudamed
EUDAMED Compliance
Medical Device Approval
Medical Device Industry
Medical Device Manufacturers
medical device regulations
Medical Device Reporting
Medical Device Safety
Medical Device Testing
Medical Device Traceability
Medical Devices
post market surveillance
Quality Assurance
Regulatory Compliance
Risk Management
UDI
Unique Device Identification

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The Need of Symbols in EU MDR

10 January 2022 0 Comments

Since there are 24 official languages in Europe, there is a need to translate information given on the labels into different languages. By using symbols as an alternative to written languages, these requirements can be met easily. In its Annex I, chapter III, 23.1.h., MDR has permitted the manufacturers to use the symbols in the […]
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Quality & Regulatory Blog

Tagged with:
eu mdr labeling requirements
medical device labelling standards
medical device regulations

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