Updated to include information on a Medtronic facility closure. Hurricane Maria is posing a threat to medical device and pharmaceutical manufacturing plants in Puerto Rico, according to a new Bloomberg report. The island is home to facilities for Johnson & Johnson (NYSE:JNJ), Pfizer (NYSE:PFE), Amgen (NSDQ:AMGN), Merck, Medtronic (NYSE:MDT) , Abbott (NYSE:ABT), Stryker (NYSE:SYK) and dozens of others, according to the report. Most of the companies created facilities […]
Russian regulators changing medical device, IVD regulations
By Stewart Eisenhart, Emergo Group The Russian government has indicated that it may loosen some rules for registration of medical devices and in vitro diagnostic products (IVDs) but also increase regulatory reviews of more substantial registration changes in the coming months. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
Working with IMARC: Your compliance partner
Our latest guide is an in-depth look at how IMARC can work with you to ensure compliance throughout the Clinical Trial Lifecycle, including case studies within the following areas of service: Monitoring, Auditing, Project Management, Safety Management, Training and Consulting. Here is a short preview of what’s in the guide: Tips for a successful compliance […]
HRS releases CIED lead extraction guidelines
The Heart Rhythm Society this week released its guidelines on device lead management and extraction for implantable cardiovascular electronic devices. The new guidelines are the result of a collaboration amongst 10 international organizations, according to the HRS. Included contributing organizations are the HRS, American College of Cardiology, American Heart Association, Asia Pacific Heart Rhythm Society, […]
Ensuring compliance at every stage in the clinical trial lifecycle
We know how nerve-wracking it can be to begin a clinical trial. The process is long and complex, and there are potential hurdles at every turn. In fact, 80 percent of clinical trials experience delays of 1 to 6 months, costing upwards of $35,000 per day. As a clinical research professional, you shouldn’t have to go it […]
MassDevice.com +5 | The top 5 medtech stories for September 13, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in […]
FDA plans to launch Premarket Approval pilot program for high-risk medical devices
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to launch a new pilot program to develop a more efficient premarket approval (PMA) market pathway for some high-risk medical devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
FDA user fees for medical device companies expect 33% rise in 2018
By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fees for medical device registrants will increase across the board for the agency’s next fiscal year starting October 1, 2017. 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 […]
Apollo Endosurgery wins CE Mark for 12-month Orbera weight loss balloon
Apollo Endosurgery said today it won an expanded CE Mark approval for its Orbera weight loss system, extending the indwell period of the gastric balloon from 6 months to a 12 month treatment period. The balloon device is designed to be inserted non-surgically in obese patients with body mass indexes of 30 to 40, the […]
FDA, Brazil ANVISA update MDSAP medical device QMS audit organizations lists
By Stewart Eisenhart, Emergo Group Regulators in the US and Brazil have updated their lists of organizations approved to conduct quality system audits under the Medical Device Single Audit Program (MDSAP). 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 […]
Giving your studies a FAIR shake
I was talking with a professional colleague recently, who referenced IMARC Research’s FAIR Shake™ method as a tool she uses regularly in her clinical research activities. It prompted me to feature our whitepaper on the FAIR Shake™ training program. Even though it is one of our older papers, it is still a useful tool for […]
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