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What is EU IVDR? A Detailed Introduction (and Role of eQMS)

What is EU IVDR? A Detailed Introduction (and Role of eQMS)

by Allan Murphy Bruun | Mar 6, 2023 | Medical Devices, Regulations

The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing in vitro diagnostic medical devices for human use and their accessories on the market. The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro...
How GMP Compliance Is Reflected in QMS (Role of eQMS)

How GMP Compliance Is Reflected in QMS (Role of eQMS)

by Allan Murphy Bruun | Mar 2, 2023 | QMS, Regulations

Good Manufacturing Practices (GMP) is a part of the Quality Management System that helps ensure products are produced and controlled according to quality requirements. Companies must ensure that all procedures impacting the product’s identity, strength, quality,...
What is ISO 15189? A Detailed Introduction (and Role of eQMS)

What is ISO 15189? A Detailed Introduction (and Role of eQMS)

by Allan Murphy Bruun | Feb 7, 2023 | QMS, Regulations

The ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical laboratories. The medical laboratory is essential to patient care since decisions on patient treatment are made based on laboratory results. The...
ISO 13485:2016 Compliant QMS [Role of an eQMS]

ISO 13485:2016 Compliant QMS [Role of an eQMS]

by Allan Murphy Bruun | Feb 7, 2023 | QMS, Regulations

The ISO 13485:2016 is an international regulatory standard that specifies the requirements for Quality Management Systems (QMS) in the medical device industry. A QMS that meets the ISO 13485:2016 requirements demonstrates a commitment to quality and customer...
21 CFR Part 820 Quality System Regulation [Role of an eQMS]

21 CFR Part 820 Quality System Regulation [Role of an eQMS]

by Allan Murphy Bruun | Nov 17, 2022 | QMS, Regulations

Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed an innovative and award-winning, extended vision foldable, presbyopia-mitigating, intraocular lens (IOL) for use by patients undergoing cataract surgery. This device will...
EU MDR Quality Management System [Role of an eQMS]

EU MDR Quality Management System [Role of an eQMS]

by Allan Murphy Bruun | Nov 8, 2022 | QMS, Regulations

The tough part for the medical device industry is that this landscape of regulations is constantly changing, and therefore, intimidating. The European Union’s Medical Device Regulations (EU MDR) which came into effect on 26 May 2021 after a three-year transition...
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