By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications. Get the full story here at the Emergo Group’s blog. The opinions […]
What “no-deal” Brexit means for medical devices
By Ronald Boumans, Emergo Group The UK will leave the European Union on March 29, 2019 – Brexit day. On that day the EU will lose an important Member State, and the UK will no longer have direct access to the 27 remaining Member States. Therefore both the EU and the UK want to work […]
These 10 medtech companies care a lot about research
These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal […]
How to ensure compliance before your medical device trial begins
By Sandra Maddock, IMARC The only way to gain the FDA approval you need to bring your medical device to market is to ensure compliance at every stage in the clinical trial lifecycle. That starts long before you sign up your first subject. The planning stage is crucial because it sets expectations for how your […]
India regulators update medical device and IVD oversight programs
By Stewart Eisenhart, Emergo Group Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs. 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 MassDevice.com or its employees.
Smith & Nephew launches portable negative pressure wound therapy system
Smith & Nephew announced today that it has launched its Pico 7Y single-use negative pressure wound therapy system (sNPWT) in Europe. The system features AirLock technology and includes an integrated Y extension that allows for two dressings to be used from one pump to allow for two wounds to be treated at the same […]
U.S. regulators to overhaul third-party 510(k) review program
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has set a goal of obviating the need to re-review 85% or more of 510(k) applications that have undergone third-party review by the agency’s 2021 fiscal year. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
FDA releases draft guidance document on civil money penalties
Brandy Chittester, Chief of Clinical Operations, IMARC The FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.” The basis for the document is to provide FDA’s […]
Don’t make these mistakes in your clinical trial: The most common FDA violations
John Lehmann, Director of Business Development, IMARC The FDA’s Bioresearch Monitoring (BIMO) inspection program ensures the protection of the rights, safety and welfare of human subjects during clinical research trials. The most recent results represent findings from more than 1,300 clinical research audits of clinical investigators, sponsors and IRBs for the 2017 fiscal year. This […]
Determining risk for in vitro diagnostic studies
Lauren Luzar, clinical research associate, IMARC In Vitro Diagnostic (IVD) devices used in clinical trials are classified according to the risk that is involved based on the potential outcomes and impact if the test does not perform properly. The risk class (Class I, II, or III) determines the review pathway for regulatory assessment. If the […]
Brazil ANVISA develops new regulations for custom-made medical devices
By Stewart Eisenhart, Emergo Group ANVISA, Brazil’s medical device market regulator, has issued a public consultation to establish new requirements pertaining to custom-made devices. 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 MassDevice.com or its […]
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