Question
In a Warning Letter to Anybattery, Inc. FDA says that replacement batteries are accessories, manufacturers must register and list, and provide a 510(k) or PMA supplements as appropriate to the device that uses the battery.In the recent draft guidance...
Hi everyone, I need to define the class of a cleanroom required for the fabrication of a medical device. While looking at ISO14644 and ISO14698 I find any sort of information on how to design, validate and operate a cleanroom, I can't find any good g...
During last week's JP Morgan Healthcare Conference, Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services (CMS), said, "In 2016, meaningful use as it has existed – with MACRA – will now be effectively over and replaced ...
Do you know what your Extended Producer Responsibility (EPR) reporting obligations are? I hadn't even heard of EPR until Graham Margetson, the CEO of Lorax Compliance, wrote me. When I saw he signed Fresenius Kabi as a client, I asked (and he agreed)...
The ongoing breakneck developments in sensor and computational processing technologies driven by mobile phones and autonomous vehicles could be applied to medical devices. One capability that might be particularly useful involves 3d scanning, which i...
Mauricio G. Pincilotti
Bioingeniero - Especialista en Calidad y Asuntos Regulatorios para Dispositivos Médicos
January 2016
Dear Colleagues,I am bothering you because I have doubts in the ways to demonstrate compliance with the Rohs 2 Directive (2011/65/EU) and I need your help to clarify this point.If the product is manufactured with RoHS components, could the manufactur...
In 2015, the Medical Devices Group surpassed 300,000 members. We gave eight free webinars, hosted the third annual 10x Medical Device Conference, and many of us met in person, talked here, and made valuable business connections. Here are the most pop...
With light readership during this holiday week, I want to thank you for being a member of this community. It's a pleasure to serve you. Take advantage of these Medical Devices Group resources for a successful 2016: MARKETING AND SALES TRAINING (Febru...
Big thanks to everyone in this forum who ever visited no2point3.com and/or asked members of Congress to rollback the 2.3% medical device tax on gross sales. See below for related links. Among the submitted discussions on the topic, I was most intrigu...
That's how much Triple-S Management Corp will pay for insufficiently protecting health information. See for what Health & Human Services said. It's not as though these rules just appeared. Group member and privacy expert Rebecca Herold writes, "Expec...
