Oct 10, 2017 | 10:00 AM | Tuesday

Event Location

Online

161 Mission Falls Lane, Suite 216, Fremont, CA 94539

Neighborhood: Upper West Side

Description

The effect of new regulatory developments on the medical device manufacture process


Start on : October 10, 2017 10:00 AM Tuesday
End on : October 10, 2017 11:30 AM Tuesday

Event Details

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: support@compliance4All.com

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