Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director
Date: December 12th & 14th 2023, Online
Duration: 6 hours | 2x 8:00 – 11:00 AM (EST), 2:00 – 5:00 PM (CET)
About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer with 4+ years of experience within the medical device industry in product development and quality & regulatory affairs. Koushik supports our courses related to quality and regulatory affairs, deploying QMS according to ISO 13485, integrating MDSAP, GMP requirements and in the preparation of technical documentation of medical devices for global regulatory submissions. Koushik is ASQ certified Medical Device Auditor (ASQ-CMDA) and holder of RAC Devices from RAPS.
Training Objectives:
- Comprehend the requirements of IEC62304.
- Gain knowledge of the implementation steps of the medical device software lifecycle processes.
- Perform the necessary risk management and software life cycle management activities.
- Relationship of IEC62304 with other standards.
Training Content:
Regulatory context & key concepts
Software classification as per Rule11 of AnnexVIII of EU MDR
Key concepts associated with IEC62304:
- Human Factors Engineering / Usability Engineering
- Risk Management
- Software Safety Classification
- Software Design Life Cycle (SDLC), Development Workflow and useful Software DevelopmentTools
- Software of Unknown Provenance (SOUPs) / Off-The-Shelve (OTS) Software
- Quality Management System
Medical device software – Software Life Cycle Processes (IEC62304):
- Chapter by Chapter, including:
- Scope, terms and definitions
- General requirements
- Software development process & the V-model, including:
- Software Architecture
- Software Integration
- Software Verification&Validation
- Software Release
- Software Maintenance Process
- Software Risk Management Process
- Software Configuration Management Process
- Software Problem Resolution Process
- Typical documentation architecture
- Software development tool examples for the documentation throughout the software development process
Correlation of IEC62304 with ISO13485.
Training Format:
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive a training certificate)
Who Should Attend:
- Software developers, Software architects, Product managers and Project leaders.
- Quality and Regulatory affairs employees of medical device manufacturers involving software.
- Anyone seeking to understand the requirements of documentation as per IEC62304 for their software product that falls under the definition as medical device (under Medical Device Regulation [MDR] 2017/745 in Europe).
Prerequisite:
Understanding on EU MDR (EU2017/745) is mandatory.
Price:
EUR 620 including course material and certificate