By Valerie Ng and Jon Tilliss, Emergo Group As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to evolve. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
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South Korea changes guidelines for medical device cybersecurity management
By Stewart Eisenhart, Emergo Group In a sign that medical device market regulators are moving toward a uniform approach to cybersecurity risk management, the South Korean government has published new guidelines referencing the UL 2900 cybersecurity standard as well as US Food and Drug Administration recommendations. Get the full story here at the Emergo Group’s […]
Key questions for the role of post-market surveillance in European MDR
By Mark Leimbeck, Emergo Group Manufacturers are beginning to take action with respect to the European Medical Device Regulation (MDR), including the Regulation’s new approach to post-market surveillance, or PMS. 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 […]
MDR and IVDR publication requirements for user information on medical device manufacturer websites
By Ronald Boumans, Emergo Group Section 23.1 of Annex I of the Medical Devices Regulation (EU) 745/2017 (MDR) and section 20.1 of Annex I of the In-Vitro Diagnostic Medical Devices Regulation (EU) 746/2017 (IVDR) pertain to requirements that looks quite simple: If the manufacturer has a website, it must publish the user information (label, instructions […]
Saudi regulators revise medical device shipment requirements
By Stewart Eisenhart, Emergo Group The Saudi Food and Drug Authority (SFDA) has published revised requirements for clearing imported medical devices at Saudi ports of entry. 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 […]
Singapore HSA implements major medical device regulatory changes
By Stewart Eisenhart, Emergo Group Medical device market regulators in Singapore have begun enforcement of key regulatory changes affecting areas such as low-risk devices, telehealth products and quality system requirements starting June 1, 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only […]
FDA plans fast-track development and marketing program for medical devices that treat opioid addiction
By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have initiated a new campaign to support development and commercialization of novel devices aimed at pain treatment and opioid addiction. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
FDA takes cautious approach to new regulations for OEM and third-party device servicers
By Joel Domanowski, Emergo Group The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services. Get the full […]
FDA is asking for more information on application forms: Here’s why that’s good for innovation and improving health
By: Dr. Christopher Leptak To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept […]
Brazil Anvisa changes market pathway for low-risk medical devices
By Stewart Eisenhart, Emergo Group Brazilian medical device regulators have approved plans to amend registration requirements for low-risk devices to more closely align with International Medical Device Regulators Forum (IMDRF) recommendations. 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 […]