Question
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...
The ISO 13485 standard is being revised and the new version will be released early in 2016. It was originally expected to be released in the fall of 2015 along with the updated ISO 9001 standard, but there were 800 comments on the DIS2 draft and a fi...
Guest post written by Medical Devices Group member Clifford Thornton and edited by Joe Hage. Remember the 1966 science-fiction movie “Fantastic Voyage” about a miniaturized submarine navigating through the human vessel system? It's becoming a reality...
Jennifer Register, MBA, RAC
Director of Regulatory Affairs at Secure BioMed Evaluations
December 2015
source: https://www.linkedin.com/groups/2070960/2070960-6080433691904008196
One of my clients sent me an email this morning asking, which upcoming regulatory changes will affect the Declaration of Conformity (DoC) for CE Marking of medical devices. They also requested a link to the new EU legislations which will come into fo...
Former $MELA CEO Dr. Joseph Gulfo's book "Innovation Breakdown" is so enlightening (and well-written) that I invited him to join the 10x faculty in May. Was his experience extreme, biased, or common? BACKGROUND • Each year, 150,000+ Americans are dia...
