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New upcoming product standard IEC 82304-1
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Maria Rickardsson:
"
IEC 82304-1 plays an important role in clarifying the requirements for software-only products"
 

Speaker info:
Maria Rickardsson has extensive experience from quality assurance of medical software and is involved in the IEC 82304-1 standardization committee ISO/IEC JWG7.



Supports You with:

- Gap analysis for fulfilment of IEC 82304-1
- Implementing IEC 82304-1 in your organization
- IEC 82304-1 compliance assessment
- IEC 82304-1 training
- Performing specific activities required by IEC 82304-1, for example software risk management

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New upcoming product standard IEC 82304-1 - closes a gap for medical device software
A free breakfast seminar from QAdvis

A product standard for software-only medical devices has for long been missing, thus creating challenges for medical device companies. This new standard, IEC 82304-1 “Health Software – Part 1: General requirements for product safety”, provides requirements for safety and security of health software products and covers the entire product lifecycle.
The new standard is not only applicable for medical device software, the scope is widened to all health software to ease for products falling in the grey zone between regulated and unregulated software.
The standard is planned to be published by the end of 2016, and is expected to become harmonized soon thereafter.

This free breakfast seminar will give you an introduction to the new standard, how it interacts with ISO 14971 and IEC 62304 and help you understand the consequences. 

Who should attend?
QA/RA professionals and personnel responsible for development of health software.
The seminar will be held in Swedish, with presentation material in English.
 
Date and location
29th of September 2016 at Kista Entré Konferens, Knarrarnäsgatan 7, 164 40 Kista
 
Agenda
08:00 - 08:30 Breakfast and registration
08:30 - 09:30 Seminar
09:30 – 10:00 Separate follow up discussion

 
Registration
Register before 22nd of September by following this link
Hurry up! Number of seats are limited.

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