Medical Device Regulatory Glossary

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Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three...

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device …

Medical Device, IVD and Pharma Glossary of Regulatory Terms

https://www.orielstat.com/blog/glossary-of-regulatory-terms/

Glossary of Medical Device, IVD, and Pharma Regulatory Terms and Acronyms Like many highly regulated industries, the medical device and pharma …

Glossary of regulatory healthcare acronyms and abbreviations

https://www.topra.org/TOPRA_Member/Resources/Glossary_of_RA_terms/TOPRA/TOPRA_Member/Glossary_of_regulatory_healthcare_acronyms_and_abbreviations.aspx?hkey=9afabfcc-ff18-4b5c-9be3-5d0a0ac3c525

Glossary of regulatory healthcare acronyms and abbreviations Glossary of regulatory healthcare acronyms and abbreviations TOPRA's compilation of more than 1,000 …

Regulatory Glossary - Regulatory Professionals

https://www.regulatoryprofessionals.com/resources/regulatory-glossary/

MDCG – Medical Device Coordination Group. MDD – Medical Device Directive. MDEG – Medical Device Expert Group. MDLO – Medical Device Liaison Officer. MDR – …

Top 100 Medical Device Acronyms & Terminology You …

https://www.greenlight.guru/blog/medical-device-terminology-acronyms

Regulatory Affairs, or RA, professionals in the medical device industry play a strategic role throughout the product lifecycle, such as ownership of a company's go-to-market strategy for satisfying legal …

Medical Device Glossary - greenlight.guru

https://www.greenlight.guru/medical-device-resources/glossary

Glossary In depth descriptions of some of the most important terms relating to medical device quality and regulatory. Browse by Category Establishing a QMS Ideation and …

Glossary for medical device manufacturers - Johner Institute

https://www.johner-institute.com/articles/regulatory-affairs/glossary-for-medical-device-manufacturers/

‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, …

EU MDR Glossary – 47 Terms You Should Know - Climedo

https://climedo.de/en/blog/eu-mdr-glossary-47-terms-you-should-know/

The European Union (EU) is approaching its highly anticipated deadline to implement the Medical Device Regulation (EU MDR). As the transition period comes to an end on May 26, 2020, a wider and clearer …

UK medical device regulations glossary: What every medical...

https://www.ignitec.com/insights/uk-medical-device-regulations-glossary-what-every-medical-device-engineer-should-know/

Below is a glossary of core medical device regulations (MDR) every engineer or quality control manager should know. It’s not an extensive list, but it’s …

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