Question
Presentation at the Personal Connected Health Alliance about regulatory trends in EU regulation of software as medical device in Vienna, May 2017Trends in EU regulation of software as medical devicePresentation at the Personal Connected Health Allian...
Does anyone have first hand experience or recommendations for a 3rd party outsourced provider for turnkey management of medical device complaint handling and postmarket surveillance services?source: https://www.linkedin.com/groups/2070960/2070960-630...
My presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDRNew legal obligations and...
There are 11 different types of software validation documents that the FDA requires. One of the documents is a rationale for the "Level of Concern." Level of Concern (LOC) is a term that the FDA uses to categorize the risk of software as a medical de...
In his insightful 10x Conference talk at http://medgroup.biz/Gulfo, Dr. Joseph Gulfo explained the official FDA mandate: To promote the public health by PROMPTLY and EFFICIENTLY reviewing clinical research and taking appropriate action on the marketi...
As originally shared by Julie Omohundro Principal Consultant at Class Three, LLC Thanks, Ginger. I've been thinking that if these devices pose low enough risk to support market entry based on certification alone, they pose low enough risk that they w...
Viky Gilles Daniel Verna
Co-Founder and VP at confinis Corp (US) - Senior Consultant at confinis ag and med-HF (Switzerland)
June 2017
Has anyone experienced an FDA 510(k) pre-clearance inspection? If yes, how long after the 510(k) submission was the inspection performed? Is the firm domestic or foreign? Did they review the DHF of the product under 510(k) review to ensure compliance...
Organizations today are faced with a growing list of new and changing standards, and keeping pace with them has become increasingly difficult. It’s hard enough to manage regulations in one country, much less multiple countries. How are the most effic...
Government agencies in the US, UK, EU and elsewhere now are mandating electronic product data submissions. And major customers including Group Purchasing Organizations and hospital networks need access to the data in a standard format. That’s where t...
There a huge increase lately by quality managers in the topic of adverse event reporting. This is partly because the new requirements in ISO 13485:2016, Clause 8.2.3 for reporting to regulatory authorities. In addition, the publication of the new Eur...
