Medical Device Software Validation Training

With the development of technology, the number of medical device software has increased. It has become important to be able to appropriately and adequately address the verification, documentation, compliance and presentation requirements specific to software-controlled devices in accordance with the legislation and applicable standards.

With MDR, a number of important requirements have been introduced in software processes. Whether it is stand-alone software or software used to operate and/or control a medical device, it must meet regulatory requirements. All medical devices with new or existing software placed on the market within the European Union must have a software validation file as part of the Technical File.

In addition, with EN ISO 13485:2016, the requirements within the scope of verification / validation processes for the software used in the quality management systems of medical device manufacturers or the software of equipment used in production processes have also gained importance. Manufacturers are required to submit a validation file for the software used in this context.

Purpose of Training:

Software validation training helps professionals operate successfully in the medical device industry by providing them with knowledge on important issues such as software security and compatibility, regulatory compliance, appropriate classification, determination of the appropriate risk class, proper planning and execution of verification and validation processes, and risk assessment.

In this context, how the (EU) 2017/745 Medical Device Regulation, standards and guidance documents affect medical device software will be discussed, and within the scope of EN 62304 Medical device software - software life cycle processes, the necessary practices will be defined to improve medical device software development, verification and life cycle processes, and within the scope of ISO 80002-2, to improve software development, verification and life cycle processes in quality management and production processes.

Content of the Training:

• Part 1:
• Regulations, Guidelines and International Standards
• Definitions (medical device, software, etc.)
• Medical device software terminology
• Medical Device Software (MDSW), Software as a Medical Device (SaMD)
• Software Classification Process
• Part 2:
• Software Development Models
• Software Design and Development Plan
• Software Design Inputs
• Software Design Outcomes
• Software Design Review
• Software Verification Techniques
• Software Verification Levels, Methods and Types
• Software Verification Planning
• Software Verification Tests
• Software Validation Techniques
• Software Design Transfer
• Management of Software Design Changes
• Software Design File
• Part 3:
• Software Risk Management Process
• Risk management Tools and Techniques
• Pre- and post-Market data collection and analysis
• Documentation requirements
• Part 4:
• Cyber ​​Security Management in Medical Devices
• Artificial Intelligence (AI) and Machine Learning (ML) and their uses in Medical Devices
• AI and ML, registration process approach under Medical Device Directive (EU) 2017/745 and US regulation
• Chapter 5:
• Verification of Software Used in the Quality Management System
• Verification of Software Used in Production Processes
• Chapter 6:
• Practical Activities
• Education Activity Questions

Who Should Participate:

• Licensing Experts
• Medical Device Software R&D Engineers
• Medical Device Software Manufacturers
• Internal and External Auditors
• Quality Managers
• Development, Production and Marketing Managers
• People who want to improve themselves in medical device software validation
• Consultants

Benefits of Education:

Ability to understand software requirements within the scope of Medical Device regulation

Ability to understand the basic concepts and requirements of EN 62304

Ability to implement medical device software life cycle processes

Ability to classify medical device software in accordance with MDR

Ability to appropriately determine the risk class of the software

Ability to perform necessary risk management and software life cycle management activities

Reference Sources:

• (EU) 2017/745 Medical Device Regulation
• EN 62304
• EN 60601-1
• ISO 80002-2
• MDCG Guides

Tuition Fee:

Please send an e-mail to info@udem.com.tr to get information about training fees. If there are 3 or more participants from the same company/institution, a 10% discount will be given. A 10% discount will be provided for participants who register early.

Education Record:

To complete the training registration, please fill out the training registration form in the link below and send an e-mail to info@udem.com.tr.

Detailed Information:

For detailed information about the training, you can contact us through the following communication channels.

Tel: +90 312 4430390

Mail: info@udem.com.tr