ComplianceOnline

The DIOM - A straightforward method for meeting FDA requirements for Design Inputs and Outputs

Instructor: Denise Wrestler
Product ID: 705593
Training Level: Intermediate
  • Duration: 90 Min
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Read Frequently Asked Questions

This webinar will provide valuable insight to design assurance and quality assurance engineers looking to simplify or condense design development activities into one document for easier traceability. This webinar is also ideal for startup companies who are unfamiliar with FDA design development regulations and are looking for a place to start in their path towards compliance.

Why Should You Attend:

A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.

The speaker has worked on numerous design development projects in Class II and Class III medical devices as well as establishing Quality Management Systems which include easy-to-understand methods to meet design development and design control requirements. This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process.

Areas Covered in the Webinar:

  • Introduction to the DIOM template
  • How to identify your design inputs
  • How to categorize your design inputs and their sources
  • Ways in which design inputs can be verified
  • Common documents and activities used as design output evidence
  • Additional requirements of design inputs and outputs

What Students Will Learn:

  • Better understanding of FDA regulations with regards to design input and output
  • An organized approach in meeting design input and output requirements
  • A simplified way to ensure design inputs and outputs are continually maintained and tracked

Who Will Benefit:

  • Quality assurance
  • Regulatory Affairs
  • Design engineers
  • Manufacturing Engineers
  • Startup companies
Instructor Profile:
Denise Wrestler

Denise Wrestler
QA and RA Consultant , CYA Medical Device Consulting LLC

Denise Wrestler, ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA’s “least burdensome approach” and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.

Denise Wrestler holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. Additionally, Ms. Wrestler holds ASQ Certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA). A contributing author to ASQ’s monthly publication Quality Progress magazine, Ms. Wrestler remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Wrestler has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation.

Follow us :
IEC 60601-1 (3.1) The New Paradigm
Vendor and Supplier Qualification Program for FDA Regulated Industries

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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