With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.
Why should you Attend:
Why do all these documents exist, and how do they affect the work your group is doing on your company's software? What does a software group need to know about them, and what changes can we expect in the near future?
Areas Covered in the Session:
Electrical equipment safety inevitably involves software
Usability requires us to understand who were working to help
Planned changes will adapt these standards to new challenges
Good engineering is our goal- compliance follows
Who Will Benefit:
Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance.