Glossary

glossary with core terms regarding EU MDR and IVDR

[Glossary] Africa Standards Harmonization: The terms you should know

  All terms regarding the regulatory harmonization in Africa that you need to know   AMA African Medicines Agency   AMRH African Medicines Regulatory Harmonization. The initiative that provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa   AU African Union. It comprises five regions and has 55 members:...

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glossary with core terms regarding EU MDR and IVDR

[Glossary] DSCSA 2023: The terms you should know

  All terms regarding DSCSA that you need to know are here:   ADR Authorized Distributor of Record. A wholesale distributor that a manufacturer designates or authorizes to distribute its products.   ASN Advanced Ship Notice. A notification of pending deliveries, usually in an electronic format. ASN is the common name for...

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glossary with core terms regarding EU MDR and IVDR

[Glossary] EU MDR and IVDR: The core terms you should know

SoftGroup prepared a set with the core terminology regarding the EU MDR and IVDR you should known navigating the new regulation demands, terms, and acronyms. The European Union (EU) is approaching its deadline to implement the Medical Device Regulation (EU MDR). As the transition period ends...

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glossary with core terms regarding EU MDR and IVDR

[Glossary] Serialization: The terms you should know

  All terms regarding serialization that you need to know are here:           3PL—Third-Party Logistics. A contracted company that provides distribution services of finished goods on behalf of another company. A 3PL never takes ownership of the product although the product is in its possession. Aggregation—The process of recording...

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