Which acronyms and terms must a Quality&Regulatory professional know?

In the field of medical and in vitro diagnostic devices, being familiar with acronyms and most used definitions regarding Regulatory Activities and Quality is very important, if not vital, in order to communicate and work successfully.

acronyms and terms Quality and Regulatory professional medical device ivd

In every domain, some acronyms and terminologies used can be confusing for professionals, due to the overlapping among several fields. However, in medical and IVD devices sector, there is no room for confusion, because a miscommunication could potentially lead to a defective device or to an adverse event, with severe consequences for people’s health.

Terms and acronyms contain nuances of meaning which we shouldn’t ignore if we want to operate correctly in activities that regulates products’ manufacturing and marketing.

For this reason, we have published a new page on Thema’s website where you can find a list with the main acronyms and terms used in the medical and in vitro diagnostic devices field, along with simple definitions. You can access it anytime.

In our glossary, you can find for example the following acronyms:

  • CAPA (Corrective Action and Preventive Action).
  • IFU (Instructions For Use).
  • IVD (In Vitro Diagnostic).
  • LBL (Label).
  • MD o DM (Medical Device).
  • NB (Notified Body).
  • PMCF (Post-Market Clinical Follow-up).
  • PMS (Post-Market Surveillance).
  • QTA (Quality Technical Agreement).
  • SOP (Standard Operating Procedure).

Do you want to know all the major acronyms and terms on MD and IVD?

Check the full list by visiting our page Acronyms and Definitions.

Having always available appropriate terms and the acronyms is a must-have tool for all professionals of the medical and IVD devices field.

Thus, we suggest add our website page in your favourite links, so that you can use it as a reference anytime while working.

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