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The DIOM – A straightforward method for meeting FDA requirements for Design Inputs and Outputs
- 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
Overview of the webinar
A DIOM, or Design Input Output Matrix, is a very common tool used by medical device companies to show compliance to FDA 21 CFR Part 820.30, Design Controls, as well as ISO 13485:2016, Section 7.3, Design and Development.
Design inputs, outputs, verification and validation all work in partnership to ensure that the device meets user needs. Design inputs are the physical and performance requirements of a device which address the device’s intended use. Design outputs are the result of the design effort, allow for evaluation of conformance to design inputs, and include acceptance criteria. Finally, design verification and validation, among other design activities and documentation, confirm that the design output meets the design input requirements. A DIOM shows compliance to this requirement within one easy-to-read, allowing for smooth-running design development projects
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
Who should attend?
Design Engineers, Quality Engineers, Quality Assurance, Regulatory Associates
Why should you attend?
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
Faculty - Ms.Denise Wrestler, ASQ CQE, CQA
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