July 31st and August 1st – 8:30 am to 4:30 pm
Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, FDA guidance documents related to software and international standards including IEC 62304 and ISO 14971. The focus of this course is interpreting the FDA QSR regulation and guidance documents for software. Each section of the FDA Design Controls regulation (820.30) is discussed from the software perspective along with corresponding requirements from IEC 62304.
In-depth discussion of critical topics such as Requirements, Software Verification & Validation, and Risk Management are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.
Who Should Attend
Software and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.
- Medical Device Definitions – FDA and EU
- Regulatory Roadmap and FDA/EU Device Classification Schemes
- FDA Regulations and Guidance Documents for Software
- Standards – ISO 13485, IEC 62304, ISO 14971, EN-14971, IEC 60601, and IEC 62366-1
- All Software is Defective
- Interpreting Design Controls for Software
- Software Development Models
- Design and Development Planning
- Design Inputs
- About Requirements…
- Requirements Exercise
- Design Outputs
- Design Reviews
- Design Verification
- Software Verification Techniques
- Design Validation
- Software Validation Process
- Design Transfer
- Design Changes
- Design History File
- Validation of…
- Software Tools used to develop Medical Device Software
- Software used in Manufacturing
- Software used in Quality Systems
- Risk Management
- Standards and Regulations
- Terms and Concepts
- Risk Management Process
- Risk Management Tools and Techniques
- Fault Tree Exercise
- Data Collection and Analysis
- Documentation Requirements
- Comprehensive reference materials included
Steven R. Rakitin has over 40 years’ experience as a software engineer including 25 years of experience in the medical device industry. He has worked with over 85 medical device manufacturers worldwide, from startups to Fortune 100 corporations. He has written several papers on medical device software risk management as well as a book titled: Software Verification & Validation for Practitioners and Managers.
He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a Senior Life member of IEEE and a member of MassMEDIC.
As President of Software Quality Consulting Inc., he helps medical device companies comply with FDA regulations, guidance documents, and international standards in an efficient and cost-effective manner.
Registration: $599 – includes all meals and background materials.