Seminar  

Software as Medical Devices


 

Friday, January 25, 2019, 09:30 - 16:00 


Venue: 
Forum MedTech Pharma e.V., Am Tullnaupark 8, 90402 Nürnberg

Objectives: 
• Get an overview about the regulatory context for Medical Device Software
• Understand the concepts and processes for Best Practice with Medical Device Software
• Learn to evaluate gaps to compliance and sequence the necessary steps 
• Know where and how to find required information

Registration:  Please register via Online-Shop.

Contents:              

  • Software as medical deviceee
  • Regulatory considerations (EU and US rules and guidance) 
  • IEC 62304 and other standards 
  • Key concept associated with IEC 62304 
    IEC 62304 – Software documentation and QMS
    Software and cybersecurity 
    ISO 13485 – Design process and software
    IEC 62304 – Content of the standard
  • Software and the new regulatory framework for Medical Devices (MDR)
    Reclassification of certain software from class I MDD to higher risk classes (MDR)
    Transition timelines & pitfalls
  • Developing a compliance plan for my class I software that gets reclassified under MDR
  • Time for one to one discussion with subject matter experts and Q&A sessions

Prerequisites: 

  • Basic understanding of Good Practices in Software Development and Innovation
  • Technical / Scientific background or commercial background linked to Medical Device software products

Target Audience:                

  • Development engineers in Medical Device companies involved in software
  • Regulatory Affairs and Quality engineering staff involved in Medical Device software
  • Entrepreneurs – Startups in Medical Device Software
     

Speakers:

Kim Rochat – Senior Partner - Medidee Services (tbc)
Scientific & Regulatory Subject Matter Experts – Medidee Services (tbc)

Participation Fee: 

600 €, members of the Forum MedTech Pharma e.V.: 480 €
* subject to 19% VAT on the Catering of € 4,75

Cancellations received before January 18, 2019 are exempt from charges. For later cancellations and for not-attendance, the full amount will be incurred.

Organisation: 

Forum MedTech Pharma e.V.
Dr. Frank Miermeister, Tel. +49 911 20671-336 / Fax –5336, E-Mail: miermeister@medtech-pharma.de

Partner:

Medidee Services GmbH
Michael Maier
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