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

Topics covered in the two-day workshop

Both workshops provide 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, both workshops include several interactive exercises...

In addition, this workshop can be tailored to the specifics of your current Quality System. As a result, you can immediately identify areas of potential regulatory exposure. By applying the guidance and recommended practices in the workshop, you can minimize any potential regulatory exposure and improve the effectiveness of your development activities.