In the United States, the safety and efficacy of medical devices are regulated by the US Food and Drug Administration (FDA), which must successfully navigate a crucial tradeoff between speed and safety in approving applications for new devices. Although a shorter (and potentially less thorough)...

This paper analyzes how features of the procurement system laid down by the EU Procurement Directives affect the analysis of competition in public procurement markets. It presents the bidding systems allowed under the EU rules and provides a general framework to assess competition concerns for...

This paper analyzes the public procurement of orthopaedic implants and related medical devices in Europe. We analyze the legal framework laid down by the EU Procurement Directives, especially with regard to awarding procedures and contractual forms. We then use data covering the universe of EU...

The public procurement of medical devices is increasingly relying on auction mechanisms to move toward more transparent procedures and to promote competition between suppliers in a market where the quality of the products matters enormously and an improper auction design could be very harmful....

This Article studied the actual effect of the United States Supreme Court's decision in Ashcroft v. Iqbal on the cohort of more than 264 federal pharmaceutical and medical device cases of every type, released from the day of the decision in Iqbal through August 31, 2010. The results of this...

This book chapter assesses the EU medical devices legal framework in light of the EU cybersecurity policy objectives and the complexity aspects inherently characterizing the healthcare sector. First, it outlines the core cybersecurity-related elements in the EU Medical Devices Regulation (MDR)...

Stipulations on de-identification and scientific research in the European General Data Protection Regulation (GDPR) help research organizations to use personal data with fewer restrictions compared to data collection for other purposes. Under these exemptions, organizations may process specific...

The public procurement of medical devices is increasingly relying on auction mechanisms to move toward more transparent procedures and to promote competition between suppliers in a market where the quality of the products matters enormously and an improper auction design could be very harmful....

What is computer systems validation (CSV)? -- CGMP regulatory requirements for production computer systems -- Maxims in CSV -- General CSV principles -- System lifecycle (SLC) -- SLC documentation (cover the data integrity in documentation) -- Management of the computer system requirements --...