On-site Training for the Medical Device IndustryDeveloping software in compliance with FDA regulations including the Quality System Regulation (QSR) and 21 CFR Part 11, as well as FDA Guidance documents and applicable international standards such as ISO 14971 (Risk Management), IEC 62304 Medical Device Software - Software Lifecycle Processes, and ISO 13485 (Quality Systems) can be challenging.
These courses are unique in that they can help your staff understand and interpret the QSR, the FDA Guidance documents, and the standards from a software perspective and in a manner that is consistent with FDA expectations and industry practice. My extensive software development expertise and first-hand knowledge of FDA expectations can help your staff learn what is and is not required as well as how to be compliant in the most cost-effective manner.
On-site CoursesClick on the course for an overview and syllabus:
- Software Development for Medical Device Manufacturers
- Software Verification & Validation for Medical Device Manufacturers
- Risk Management for Medical Device Manufacturers
Brown bag seminarsBrown bag seminars are a collection of short, focused, informal seminars aimed at helping organizations improve predictability, productivity, quality, and time-to-market. By presenting focused topics in a short (about an hour) informal setting, your staff can learn new methods and techniques that can help them in their work without affecting time-critical project schedules.
Brown bag seminars can also be used as a forum for discussing compliance issues and for sharing ideas and experiences. Brown bag seminars can be presented in person in the New England area or using browser-based remote meeting tools.
Brown Bag Seminar Topics
- Overview of Software Development for Medical Devices
- Overview of Risk Management for Medical Devices
- Documenting Complaints and Root Cause Analysis
- Improving the Effectiveness of Medical Device Software Validation
- Overview of 21 CFR Part 11—Electronic Records and Signatures
TailoringEach of the courses and seminars can be tailored to meet your specific needs and all are based on the simple principle that real learning occurs when people are actively involved.
I frequently review a client’s Quality Manual and relevant SOPs in advance. This way, I can prepare a brief assessment of your current Quality System and how it meets (or doesn't meet) the regulations and standards, which can then be discussed as part of the training session.