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R&D Workshop: Design History File Contents and Remediation
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When: Tuesday, November 13, 2018
7:30am - Registration; 8-9:30am - Program
Where: NITA Training Center
1685 38th Street
Suite 200
Boulder, Colorado  80301
United States
Contact: Daniela Blagoeva

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Tuesday, November 13, 2018 
7:30am - Breakfast & Registration 
8:00-9:30am - Program

NITA Training Center 
1685 38th Street Suite 200 
Boulder, CO 80301

Program Summary:

Companies commonly face the challenge of assessing and updating design history files (DHF) as a result of design obsolesce, product updates, transfer of design ownership and changing regulatory requirements. This seminar will provide an overview of DHF requirements, presents a framework for DHF gap analysis and remediation, and offer a checklist of critical DHF assessment areas for complex medical devices.

Presentation Topics:

  1. What is the Design History File?
  2. Why is an effective DHF good for business?
  3. DHF Checklist
  4. FDA Critical DHF assessment area
  5. Common DHF Deficiencies
  6. When / Why is a DHF gap analysis warranted

Presenter:  Greg Schultz

Greg Schultz has 30 years of product development experience, almost entirely in the medical field.  He has extensive experience developing software ranging from real-time embedded systems to Windows-based applications.  Greg has experience developing software used in both Class II and Class III medical devices, complying with the IEC 62304 Software Life Cycle Processes standard for both new and legacy devices.  Prior to co-founding Design Solutions, Greg held lead software engineering and management positions at Angeion, Medtronic, Beckman Coulter, CNS Inc. and ACIST Medical Systems.   Greg has a BSEE degree from the University of North Dakota and an MBA from the University of St. Thomas

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