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Life Science QMS (The Essential Guide)

Life Science QMS (The Essential Guide)

For all industries, a Quality Management System (QMS) is essential to formalize the processes,...

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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)

The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing...

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

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

Good Manufacturing Practices (GMP) is a part of the Quality Management System that helps ensure...

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10 Benefits of a Quality Management System (QMS)

10 Benefits of a Quality Management System (QMS)

The benefits of a Quality Management System (QMS) are numerous and wide-ranging. A QMS will help...

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MDSAP: Medical Device Single Audit Program

MDSAP: Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single...

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

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

The ISO 15189:2022 is an international standard that specifies the requirements for quality and...

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

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

The ISO 13485:2016 is an international regulatory standard that specifies the requirements for...

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CE Marking for Medical Devices [Step-by-Step Guide]

CE Marking for Medical Devices [Step-by-Step Guide]

To sell and market your medical device across the European Union (EU), you must have a CE marking...

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

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

Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed...

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Vendor Management Process in Clinical Research [How-To Guide]

Vendor Management Process in Clinical Research [How-To Guide]

Imagine yourself in the shoes of a lead clinical investigator or a seasoned product manager...

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Recent Posts

  • Life Science QMS (The Essential Guide)
  • What is EU IVDR? A Detailed Introduction (and Role of eQMS)
  • How GMP Compliance Is Reflected in QMS (Role of eQMS)
  • 10 Benefits of a Quality Management System (QMS)
  • MDSAP: Medical Device Single Audit Program

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