recorded on 07.12.2015
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The increasing number of Apps for Smartphones and other software types developed and distributed by pharmaceutical companies to patients, physicians or other customers brings a new product class to the industry. This new product class – software – potentially falls under the Medical Device regulations. If its intended use is covered by the definition of a Medical Device it needs to be developed and operated according to the requirements for Medical Devices, and it also needs to have a regulatory clearance.
The goal of this webinar is therefore to provide you with an overview about Medical Software, allowing you to evaluate whether there is a need for actions in your company.
The aim of the webinar is to provide you with an overview about relevant aspects of Medical Software:
Introduction – Software distributed by Pharmaceutical
Medical Software vs. Promotional Software
Overview about regulations for Medical Software (mainly in EU and US)
Challenges with Medical Software
The webinar targets executives and staff from quality and information technology units who are in charge of Software with Medical purpose (e.g. Mobile Apps, Desktop Software, Websites). It also addresses Qualified Persons, responsible for the review and release of Medical Software or Combination Products.
Bayer Pharma AG, Berlin, Germany
Since 1999 Torsten Kneuss has been working with pharmaceutical packaging materials, including several years within the fields of packaging quality control and packaging development. Since November 2010 he has been Operations Manager, responsible for pre-filled syringes and medical devices. For the past two years he is also responsible for Medical Software, mainly the launch preparation of a system consisting of Patient Apps and Software for health-care professionals.