Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a...
Whitepapers
The History of the FDA
One of the oldest protection agencies in the US federal government, the Food and Drug Administration’s modern...
Enforcement Mechanisms Available to the FDA
The mission of the Food and Drug Administration is to protect public health by ensuring compliance of products and...
Industry 4.0 and Medical Devices
As we progress through the 4th Industrial Revolution, technology is advancing quicker and quicker. More and more...
Optimizing CAPAs in the Medical Device Industry
In this whitepaper, we will explore how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”. This paper will also discuss the purpose and basic principles of CAPAs, as well as how the process has developed over time.
Understanding Cybersecurity in Medical Devices and Applications
One of the major pillars of the current Industry 4.0 is Automation. Indeed, technology is intervening in almost every...
Post-Market Clinical Follow up Studies Under EU MDR and IVDR
On May 5, 2017, the Active Implantable Medical Devices Directive (90/385/EEC -- AIMD) and the Medical Devices...
The FDA’s Response to COVID-19
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, was officially declared a pandemic back in early...
Medical Device Single Audit Program (MDSAP)
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program...
Clinical Evaluation Reports Under the New EU MDR
The new EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, 2017,...
Quality Function Deployment (QFD) for Design Controls
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a...
The Future of Enterprise Quality Management Software (EQMS) – Part I
The future of enterprise quality management software is changing. Quality professionals across the globe are dealing...
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