Quality Training

Quality Management Systems & 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 62366 Application of Usability Engineering to Medical Devices

Participants will be given practical exercises to complete throughout the course to aid learning and develop practical validation skills.

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 5 approach 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.

Upcoming dates:

No training dates available at the moment.