QMS & Medical Device Software Validation
This 3-day course 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 and will cover the applicable requirements from both the Europe and the US.
Dates & Location
Tessday, 06th - Thursday 08th October 2020
09.30 - 17.00
What will I learn?
Participants achieve the following learning outcomes from the programme;
- Apply the principles of Software Validation to QMS Software.
- Implement the Validation Life Cycle and GAMP 5approach to QMS Software
- Apply Quality Risk Management techniques.
- Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ.
- Apply the requirements of 21 CFR part 11 in relation to Electronic Signatures & Records.
- Apply the principles of Medical Device Software Development and Validation.
- Identify the requirements of EN IEC 62304, EN IEC 62.
- Identify and generate the documents necessary to implement the Development/ Validation Life Cycle approach to Medical Device software.
- Implement Requirements for S.O.U.P.
- Implement software maintenance requirements.
- Implement software usability requirements.
- Write key validation requirements such as User Requirements and Test Cases
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.
Members: €540 per delegate (includes 35% subsidy from Connected Health Skillnet)
Non members: €830 per delegate
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.