By: Suzanne Fitzpatrick, Ph.D. There are many things you might envision putting on a chip. It’s unlikely that a human organ is one of them. But creating human organ systems in miniature on micro-engineered chips about the size of a AA battery is a revolutionary testing technology that has captured the attention of food scientists […]
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10 questions companies affected by European MDR should be asking
By Ronald Boumans and Stewart Eisenhart, Emergo Group Now that the European Parliament has voted to approve the Medical Device Regulations (MDR), many medical device companies active in Europe have begun mapping out how the new Regulations will impact their business. Based on feedback from clients as well as our own analysis of the MDR, […]
China FDA getting rid of medical device testing fees
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) appears to have stopped charging substantial fees for in-country registration testing of medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of DrugDeliveryBusiness.com […]
Common medical device QMS problems: difficult auditees
By Stewart Eisenhart, Emergo Group Part three of our blog series on common medical device quality system audit problems examines ways to deal with difficult auditees in order to successfully obtain information and evaluate processes. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
European Parliament approves new medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The European Parliament has officially voted to approve the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), allowing implementation efforts for these major new regulations to proceed. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
MFDS launches new medical device recall system in South Korea
By Stewart Eisenhart, Emergo Group The South Korean Ministry of Food and Drug Safety (MFDS) has rolled out a new system for medical devices subject to recalls in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily […]
Saudi Food and Drug Authority plans changes for medical device marketing application
By Stewart Eisenhart, Emergo Group Saudi Arabia’s medical device regulator, the Saudi Food and Drug Authority (SFDA), plans to introduce changes to the application process for obtaining market authorization in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]
Singapore changes medical device field safety notice requirements
By Stewart Eisenhart, Emergo Group Singapore’s medical device market regulator now requires registrants issuing field safety notices (FSNs) regarding their products to copy managers of affected local healthcare facilities. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect […]
Russian technical file requirements for medical devices and IVDs clarified by regulators
By Stewart Eisenhart, Emergo Group The Russian Ministry of Health has issued a new regulation to explain longstanding but unofficial technical file and instructions for use requirements for medical device and IVD registrants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
FDA in India – championing a culture of quality
By: Mary Lou Valdez One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the safety and security of food and the safety and efficacy of […]
