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

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 MedicalDesignandOutsourcing.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

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 only

FDA takes cautious approach to new regulations for OEM and third-party device servicers

Joel Domanowski, Emergo Group The U.S. FDA 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 story here at the

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

FDA clarifies multiple-function medical device oversight policy

Stewart Eisenhart, Emergo Group New guidance from the U.S. Food and Drug Administration addresses premarket authorization requirements for multiple-function products with at least one function that qualifies as a medical device. 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

7 QMS tools to demonstrate compliance with 21 CFR Part 820 for medical devices

Rachel Beavins Tracy, EtQ 21 CFR Part 820 contains a huge number of “shall” requirements for medical device manufacturers. While it may seem impossible to meet so many requirements, a well-constructed Quality Management System (QMS) provides an excellent starting point and framework for compliance. So, how can manufacturers use the QMS to demonstrate compliance with

Eudamed completes actors module testing

By Ronald Boumans, Emergo Group On April 12, 2018, 20 representatives of stakeholders from industry and European Competent Authorities (CAs) had the opportunity to test the first Eudamed module. This module will be used for entering actor data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post

Health Canada launching new unit for digital health technology licensing

By Stewart Eisenhart, Emergo Group Medical device regulators at Health Canada are developing a more targeted oversight approach for digital health technologies such as mobile medical applications. 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

What Brexit withdrawal means for MDR implementation in the U.K.

Ronald Boumans, Emergo Group Negotiators discussing how the U.K. will leave the European Union have reached a draft Withdrawal Agreement about the Brexit transition period. The transition will start on March 29, 2019 and will end on December 31, 2020. Instead of 12 months from now, there are 21 months to prepare. This is still