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From Medical Design & Outsourcing

• China has a new medical device classification catalog: what you need to know
  Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018. […]
• FAIs: When do you use conventional versus digital inspection methods?
  Tony Holtz, Proto Labs First article inspections (FAIs) can be time-consuming and costly, but they are a necessary step in getting medical devices from product design to production. Medical device manufacturers are likely familiar with the process, although most leave it to suppliers to handle. Even if that is the case, device makers should get […]
• Medtech complaint handling: Is there something to complain about?
  Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Only […]
• 10 of the world’s largest medical device companies
  When it comes to the largest medical device companies, it’s a changing cast of players – as demonstrated once again in Medical Design & Outsourcing’s latest Big 100 list. We pulled financial regulatory filings and reached out major companies in some cases to create a list of the 100 largest medical device companies in the […]
• MPR presenting devices and mobile monitoring at DeviceTalks Boston
  MPR is working to solve energy shortages by helping to develop the next generation of technologies and improving the operations of existing power plants and is applying advanced technologies to ensure cleaner air and water. MPR is developing medical devices and biotechnology products that offer solutions to world health problems, and its on the frontier […]
• Webinar about combination products: Bridging the gap between pharma and medical devices – Oct. 18
  Wednesday, October 18, 2017 11:30am EDT / 8:30am PST   We will provide a new understanding of key topics that separate the regulatory and quality process for drugs and combination products/drug delivery devices.  We understand the process for drug development and certification varies greatly from the process for medical devices.  We will cover the intricacies […]
• FDA’s medical gas guidance offers clarity to manufacturers
  FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]
• Eastridge Workforce Solutions acquires Operon Resource Management
  Eastridge Workforce Solutions (San Diego, Calif.) recently announced that it has acquired Operon Resource Management (Lowell, Mass.). The financial details of the deal were not disclosed. Operon’s medical device recruitment solutions will add on to Eastridge’s history of helping medtech manufacturers with their workforces. The clients from both companies will have access to specialized services that […]
• Webinar: How late 2017 has changed medtech – Oct. 11
  Wednesday, October 11, 2017 2:00 PM EST / 11:00 AM PST       When it comes to news out of the U.S. government: one word could sum up what it means for the medical device industry: “uncertainty.” It was true at the start of 2017. And it is even truer today. The effort to […]
• Medtech stories we missed this week: Sept. 15, 2017
  From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to […]
• Nypro reopens renovated Illinois design and manufacturing facility
  Nypro has officially opened the doors of its recently expanded Gurnee, Ill. location after having a ribbon cutting ceremony that included Mayor Kristina Kovarik and other company officials. The facility has almost doubled in size with the new expansion and is bringing 60 new jobs to the local area. The expansion also enhances specialized capabilities […]