5 mistakes that can turn your product registration into a money drain

Medical device registration may seem straightforward but is actually prone to potentially costly mistakes.  Medical device organizations are required to register medical devices with notified bodies in all countries where they sell those products. This process is fairly well understood and expected. However, there are pitfalls in the practice of compiling the dossiers to register,

R&Q to tout regulatory consulting and more at DeviceTalks Boston

Regulatory and Quality Solutions LLC (R&Q) provides regulatory and quality consulting and engineering to medical device companies. From strategy to tactical implementation, R&Q partners with clients and seeks to enhance the commercialization and post-market processes for medical devices. Featured services: R&Q can support your transition from ISO 13485:2003 to ISO 13485:2016 with strategic planning to

Did Congress just kill medical device innovation?

The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston. That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for

NuVasive wins FDA nod for redesigned Magec system

NuVasive Inc. (NSDQ:NUVA) said today it won FDA 510(k) clearance for its redesigned Magec magnetically controlled growth modulation system. The San Diego, Calif.-based company’s Magec system uses magnetic technology and adjustable growth rods to treat early-onset scoliosis, and features the company’s Reline small stature system. The Reline small stature platform is a pediatric deformity fixation system which […]

China wants to dominate medtech: Here’s how

Under its “Made in China 2025” plan, the Chinese government seeks explosive growth in biomedical and high-end medical device manufacturing. Grace Fu Palma, China Med Device In 2015, the China State Council issued a 10-year manufacturing plan called “Made in China 2025.” The  goal is to elevate the “giant but weak” Chinese manufacturing industry into

GI Dynamics CEO is optimistic about Endobarrier’s future: Here’s why

GI Dynamics (ASX:GID) CEO Scott Schorer has had an uphill battle over the past year. His company has faced regulatory and compliance issues, negative shareholder sentiment and a number of other concerns. But Schorer and his team are committed to righting the ship and saving a product they see as having no equal in the current

How to work with the new FDA

Here’s how medical device makers can capitalize on the strategic priorities and transparency initiatives at FDA’s CDRH. Lisa Olson, RCRI Scott Gottlieb has now settled into his role as FDA’s new commissioner and is putting his stamp on the agency. Interestingly, he has started with some very specific points of focus that have bubbled to

FDA user fees for medical device companies to rise 33%

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 Oct. 1. 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

PeekMed receives CE Mark and ISO certification

PeekMed (Braga, Portugal) recently announced that it has received ISO 13485 certification and CE Mark for its flagship 3D pre-operative system for orthopedic surgeons. The new CE Mark allows PeekMed to sell its system in Europe. It is currently working on obtaining FDA 510(k) approval to market in the U.S. PeekMed helps orthopedic surgeons plan

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

FDA clarifies Early Feasibility Study program for innovative medical devices

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

Medtech stories we missed this week: Aug. 25, 2017

From InspireMD’s Swiss distribution deal to CoreLink’s stackable guide wire launch, here are seven medtech stories we missed this week but thought were still worth a mention. 1. InspireMD announces Swiss distribution deal InspireMD announced in an Aug. 25 press release that it has signed an agreement with 1a Medical to distribute the CGuard EPS (Embolic

NxStage Medical’s Todd Snell talks FDA, Brexit & regulatory strategy

Between the consequences of Brexit and a new commissioner at the FDA, executives across medtech are bracing for change within the global regulatory landscape. NxStage Medical‘s (NSDQ:NXTM) SVP of quality assurance, regulatory & clinical affairs, Todd Snell, spoke with MassDevice.com editor Sarah Faulkner about what he’s observing from his post at the Lawrence, Mass.-based company. Faulkner: What has

The U.K. wants to speed up medtech approvals: Here’s how

The U.K. is in the midst of changes to the appraisal pathways for assessing and funding health technologies, according to RTI-HS staff attending the recent  National Institute for Health and Care Excellence (NICE) 2017 conference. Caroline Ling and Jessica Costello, RTI-HS We and other RTI-HS staff recently attended the National Institute for Health and Care Excellence (NICE) 2017

Could this new assay reduce the need for animal tests?

American Preclinical Services has developed a novel assay that its creators think could replace the thromboresistance animal tests for medical devices – which use dogs, sheep and pigs. Mark E. Smith, American Preclinical Services Blood-contacting medical devices and the materials from which they are constructed must meet stringent safety criteria prior to regulatory approval for