Software Development for Medical Device Manufacturers

Two Day Workshop

Many medical device manufacturers find it difficult to develop software in compliance with FDA QSR regulations and ISO 9001 requirements. This two-day comprehensive workshop will provide your organization with practical guidance and recommendations for a software development process that complies with FDA QSR, FDA Guidance documents, applicable international standards in a manner that is flexible, cost-effective, and makes good business sense...

Topics covered in the two-day workshop:

Introduction FDA Regulations and Guidance Review and Discussion of International Standards and Technical Reports Types of Medical Device Software Medical Device Documentation: Procedures, Work Instructions and Records Interpreting Design Controls for Software Review of All Design Control Sections from Software Perspective Software Development Models Software Verification Process About Requirements… Unit and Integration Testing Design Reviews Verification Exercise... Software Validation Process Testing Overview Testing Levels, Methods, and Types Test Planning Testing Measures Common Testing Problems Validation Exercise... Risk Management for Software-based Medical Devices Standards and Regulations Terms and Concepts Risk Management Process Risk Management Tools and Techniques Fault Tree Exercise Data Collection and Analysis Documentation Requirements Validation of Software Tools Used to develop Device Software Validation of Software Used in Manufacturing and Quality Systems Summary

The focus of this two-day course is on interpreting FDA Regulations and Standards for Medical Device Software. Specifically, the course includes a comprehensive discussion of Design Controls and how they can be interpreted for medical device software

Topics discussed in depth include:

• Software Development Process

• Design Reviews for Software

• Software Validation Testing

• Risk Management Techniques based on ISO 14971

• Validation of Software Development Tools

• Validation of Software used in Quality Systems and Manufacturing

To help reinforce critical skills related to risk management, several interactive exercises are included in the workshop. In addition, examples of cost-effective processes and procedures that meet the regulations and comply with applicable standards are discussed.

Tailoring
	This workshop can be tailored to meet your specific needs. By reviewing your Quality Manual and relevant SOPs, an assessment of your current Quality System and how it meets (or doesn't meet) the regulations and standards can be provided as part of the workshop. Call for details...