By Teemo Chang and Stewart Eisenhart, Emergo Group The Chinese government has issued draft changes to the country’s medical device regulatory framework that would allow easier market access for foreign manufacturers. 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 […]
How medtech can prepare for the consequences of a “Hard Brexit”
By Ronald Boumans, Emergo Group On July 5, the Dutch Ministry of Health organized an informative meeting for the medical field about the possible impact the UK’s exit from the European Union (EU), Brexit, might have. This is considered a very important issue that may impact many aspects of the Dutch – and European – […]
9 trends in medical device user interface design
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 […]
Medtech stories we missed this week: July 13, 2018
From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump […]
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 […]
Medtech stories we missed this week: June 22, 2018
From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in […]
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 […]