Question
Our wearable device has been accepted by many doctors and parents from Argentina. After being interviewed by one of the most important news company, the Argentine Department of Healt has contacted us. Now, we are looking for manufacturing companies o...
A colleague asked me today about a possible conflict between the date that should be used for Block B4 of the MedWatch 3500A form. Per the 3500A Form Instructions, Block B4 should be date the initial reporter provided the information about the event ...
As we enter the season of giving thanks, what medical device are you personally thankful for having or existing? What one device - great or small - has helped you (or a loved one) live a productive and happy life?source: https://www.linkedin.com/grou...
Last night I published a blog (http://www.medicaldeviceacademy.com/blog) about how to write a template for the device description section of a 510(k) submission (i.e., Section 11). As with all things I do, I have three basic tactics:use a harmonized ...
One in three Medical Devices Group members is in marketing, sales, and business development. So we created MDMS, an executive education program for Medical Device Marketing and Sales Professionals at the University of South Florida. It's February 1-3...
The number of medical apps grows by the day, also the capability of such apps continues to improve. With the internet being effectively border-less, is it inevitable, that the regulatory bodies will not be able to control or regulate a significant po...
Despite emphasis on patient engagement, even the most committed patient can have trouble getting recordsOn trying (still) to access one's health data electronically | Healthcare IT NewsA few months back, our columnist shared her struggle to obtain el...
Dear fellow professional,I would like to ask your opinion on what follow.Thank you to all the contributors.According to MEDDEV 2.1/1 and Directive 93/42/CE, the intended use of the accessory must be such as to enable a device to be used in accordance...
Are they covered by the European virtual manufacturers certification, or are they also themselves viewed as manufacturer under the regs with associated responsibilities. Whose manufacturer detail should be on the pack?source: https://www.linkedin.com...
Dan Schultz
Piezo Specialist/Business Development Manager at Physik Instrumente (PI) GmbH & Co. KG
October 2015
I had a colleague mention that there may be HIPPA regulations against re targeting customers that visit my company website? My company simply sells and supports medical device equipment such as AED's, Defibrillator's, Patient Monitors, etc... Are the...
