Quality Training

QMS & Medical Device Software Validation

Objectives


This 3 day programme will give attendees a good grounding in the requirements for Medical Device Software validation and Quality Management Systems (QMS) Software validation. The course will cover the implementation of those requirements through Software Validation and Medical Device Software Life Cycles Processes. The course will cover the applicable requirements from both the Europe and the US. The course will include practical exercises covering the implementation of those requirements.

Content includes


Day 1&2:
  • Regulations and Guidelines for Software Validation
  • The Software Validation Life Cycle
  • Key Validation documents/activities
  • Electronic Signatures and Records
Day 2&3
  • Risk Assessment: ISO14971 and IEC/TR 80002-1
  • Contents of EN IEC 62304
  • Design Control Requirements of 21 CFR Part 820
  • Key Validation documentation/activities
  • EN IEC 62365 Application of Usability Engineering to Medical Devices

Who should attend


Developers of Medical Device Software, and IT, Engineering and Quality personnel who need to gain a foundation in the principles and practices of QMS and Medical Device Software Development and Validation.

Upcoming dates:

Location
Dates

Galway, venue tbc, Galway
06th - 08th Oct 2020 (9:00 - 17:00)
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Course

QMS & Medical Device Software Validation

Training Days

3 days

Training Locations

Dublin, Galway, Limerick, Online, Westmeath

Course Cost

Member rate: €540
Non-member rate: €830
* Cost quoted per person

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