Software Development for Medical Device Manufacturers

One Day Workshop

Many medical device manufacturers find it difficult to develop software in compliance with FDA QSR regulations, FDA Guidance documents and applicable international standards. Both a one-day and two-day workshop are available that provide your organization with practical guidance and recommendations for a software development process that not only complies with regulations in the QSR, ISO 14971, and ISO 13485, but is flexible, cost-effective, and makes good business sense...

Topics covered in the one-day workshop: Introduction FDA Regulations and Guidance International Standards and Technical Reports Interpreting Design Controls for Software Software Development Models About Requirements… Software Verification Process Design Reviews Unit and Integration Testing Software Validation Process Testing Overview Testing Levels, Methods and Types Risk Management for Software-Based Medical Devices Standards and Regulations Terms and Concepts Risk Management Process Risk Management Tools and Techniques for Software-based Devices Fault Tree Exercise Data Collection and Analysis Documentation Requirements Summary

This workshop provides specific examples of processes and procedures that meet the FDA regulations and allow work to be performed in a flexible and cost-effective manner... To help reinforce critical skills, this workshop includes an interactive exercise on Risk Management...

Tailoring
	Both of these workshops 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...

For further information,

call Steve Rakitin at 508.529.4282

or e-mail him at steve@swqual.com