What are Standards for Medical Device Software -2017

Overview:
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:
Software Developers
Business Analysts
Requirements Analysts
Product Managers

Speaker Profile:
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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]