New medical device rules change India’s Authorized Agent role

By Stewart Eisenhart, Emergo Group The role of in-country representatives for medical device manufacturers registered in India will change substantially under the country’s new Medical Device Rules published earlier in 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

The top medtech stories of early 2017

The new Trump administration and Republican Congress – and all the accompanying change and uncertainty –is the major story for the medical device industry. But there are many other medtech stories worth noting from the first quarter of 2017. There was an FDA warning over Abbott’s Absorb bioresorbable stent, a continued spate of M&A deals, a

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Guided Therapeutics reveals details of $50m LuViva deal in China

Guided Therapeutics (OTC:GTHP) said that it inked an exclusive licensing agreement with Shandong Yaohua Medical Instrument Corp., to manufacture its LuViva advanced cervical scan system and related disposables. The deal also gives SMI exclusive distribution rights in China, Macau, Hong Kong and Taiwan. SMI is slated to pay a $1.0 million licensing fee in 5 installments until

This Trumpf laser could solve your UDI compliance problems

Trumpf is touting a new laser and software module that enables UDI marking from a single source. Medical device makers can create corrosion-resistant marks on highly reflective materials using ultra-short pulsed lasers. By combining a marking laser with a UDI software module, Trumpf offers both components from a single source. This helps manufacturers to comply with

Trump proposes higher FDA fees for drug, medical device FDA registrants

By Stewart Eisenhart, Emergo Group US Food and Drug Administration user fee increases in the Trump Administration’s proposed 2018 federal budget would disproportionately impact smaller medical device companies, as these firms make up the majority of the US medical device industry. Get the full story here at the Emergo Group’s blog. The opinions expressed in

Medical device firms have little understanding of European MDR, IVDR

By Stewart Eisenhart, Emergo Group Many medical device companies have yet to fully absorb the ramifications of the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) for their compliance efforts, according to Emergo’s 2017 Global Medical Device Industry Outlook. Get the full story here at the Emergo Group’s blog. The opinions expressed

Malaysia plans to ratify ASEAN Medical Device Directive

By Stewart Eisenhart, Emergo Group Malaysia’s medical device market regulatory agency has provided updates on various fronts at a recent seminar attended by Emergo consultants. 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 or

New CQI/IRCA-Certified lead auditor training based on ISO 13485 and International MDSAP

NSF International, a global public health and safety organization, is now offering QMS Lead Auditor Training based on both ISO 13485:2016 and international Medical Device Single Audit Plan (MDSAP) requirements. The five-day training program is the first international MDSAP- and ISO-compliant medical device auditing course to be certified by the Chartered Quality Institute (CQI)/International Register of Certificated

QMS compliance: Here are the basics

Rachel Beavins Tracy, Verse Solutions U.S. FDA requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks. But meeting FDA requirements around software validation and change control isn’t always straightforward,

Medtech stories we missed this week: March 17, 2017

The FDA awarded 510(k) clearance to a couple of medtech companies this week while others received tax breaks and incentives, including a local tax break for a $154 million Stryker R&D facility planned in Michigan. Here are some medtech stories we missed this week but thought were worth mentioning. 1. FirstRay wins FDA 510(k) clearance

510(k) submissions to FDA declining

By Stewart Eisenhart, Emergo Group The number of US-based medical device manufacturers submitting 510(k) premarket notification applications to the Food and Drug Administration has decreased over the past four years, according to a new Emergo study, while applications from European and Asian firms have increased. Get the full story here at the Emergo Group’s blog.

FDA proposes exempting 337 Class II devices from 510(k) requirements

By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration (FDA) have proposed exempting hundreds of moderate-risk devices from 510(k) premarket notification requirements as the agency begins implementing components of the 21st Century Cures Act passed in late 2016. Get the full story here at the Emergo Group’s blog. The

Senate confirms Verma to head CMS as debate intensifies over Obamacare replacement

The U.S. Senate voted yesterday 55-43 to confirm Seema Verma to head the Centers for Medicare and Medicaid Services. Verma is the founder & CEO of SVC Inc, a healthcare consulting firm, and worked with now-Vice President Mike Pence when he was governor of Indiana to redesign the state’s Medicaid program. Get the full story

Medtech stores we missed this week: March 10, 2017

The FDA and Health Canada cleared a couple medical devices while other companies touted their device studies. Here are medtech stories we missed this week but were still worth mentioning. 1. FDA clears Medela’s neonatal enteral feeding device Medela has received 510(k) clearance from the FDA to market its ENFit Low Dose Tip eternal syringes,

Report: Gottlieb is Trump’s top pick for FDA head

Former FDA deputy commissioner Scott Gottlieb is the Trump administration’s top choice to head the agency, according to a Bloomberg report. Gottlieb has held several senior positions at the FDA during the George W. Bush administration, and has regularly spoken on plans to lower prescription drug cost through modernizing the federal watchdog’s approval process, according