Ashton Steinhagen, lead clinical research associate, IMARC When the FDA reviews a new drug application (NDA), they typically review multiple data sets, summaries, and other reports provided by the Sponsor. However, the amount of information that is usually released by the FDA at the time of approval was limited at best as well as sporadic. […]
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 is the future of harmonized standards?
Nele Zgavc, BSI Group For national standards bodies, 2018 brings a big challenge as we aim to generate appropriate revisions of key standards that manufacturers use to show compliance to essential requirements. These harmonized standards include an Annex ZA/ZZ which represents the correlation between the requirements in the EU Medical Devices Directives (MDD, AIMD, IVDD) […]
What Brexit withdrawal means for MDR implementation in the U.K.
By Ronald Boumans, Emergo Group Negotiators discussing how the UK will leave the European Union have reached a draft Withdrawal Agreement about the 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 […]
Fischer Medical wins FDA 510(k) for Bloom2 cardiac stim
Fischer Medical said today it won FDA 510(k) clearance for its Bloom2 cardiac electrophysiology stimulator device designed to aid in the diagnosis and treatment of cardiac rhythm disorders. The newly launched Bloom2 is a digital version of the company’s Bloom device and features a modern, improved user interface while maintaining the tactile feel of the […]
How GDPR affects personal data use in clinical trials
Lisa Wickert, Clinical Research Associate, IMARC On May 25, the General Data Protection Regulation (GDPR) goes into effect in the European Union (EU). This regulation has a broad scope beyond companies performing clinical research – all personal data falls under this jurisdiction which includes web search engines, social media, and much more. But specifically, how […]
Why clinical vendor audits are important
John Lehmann, Director of Business Development, IMARC In today’s business environment, it’s important to have reliable partners who can help you achieve your business goals and objectives. In clinical research, this is especially true. One proactive way to ensure your trial partners are meeting your standards is to conduct vendor audits. Clinical vendor audits assess […]
What makes a well-controlled clinical trial?
John Lehmann, Director of Business Development, IMARC A well-controlled clinical trial is much like a well-controlled experiment. They are both rooted in the cornerstone of the scientific method. What exactly is a clinical trial? According to clinicaltrials.gov, “In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan […]
HFES conference to host workshop on risk analysis for summative usability tests
By Kate Jablonski, Emergo Group A workshop session at the 2018 International Symposium on Human Factors and Ergonomics in Health Care will provide insights into conducting residual risk analyses for summative usability tests for medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the […]
China CFDA proposes regulatory framework for 3D-printed medical devices
By Stewart Eisenhart, Emergo Group Medical device market regulators at the China Food and Drug Administration (CFDA) have published new guidance proposing registration requirements for devices produced via 3D printing or additive manufacturing. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Brain implant for some blind people shows benefits of FDA’s Breakthrough Device Program
Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation FDA’s Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies. Consider Second Sight […]
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