Why Medical Device QMS and UDI Data Quality Matters

Medical Device, Medical Device Manufacturing & Supply Chain,
  • Thursday, August 11, 2022

Are companies ready when product data is requested? Is the current version stored in an excel workbook — a hard copy in a filing cabinet or residing on a PC with a team member? When data is needed, the integrity and curation process become important. Just storing product data is not enough. It is time to leverage medical device QMS (Quality Management Systems) and improve product data quality.

During product development, strategic Product Lifecycle Management/Quality processes along with systematic centralization can make or break compliance milestones and post-market activities. In addition, the Unique Device Identification (UDI) data submitted to global health authorities forms a key component in communicating product data to downstream users.

To reach a competitive edge, companies with the best ‘data hygiene’ are prepared when patient or compliance issues arise. Identifying what is required for a portfolio can be difficult, but it is important to get it right. Supply chain, healthcare providers and patients depend on accurate product data.

In this webinar, industry veterans will discuss questions around ‘lessons learned’ from their work in providing solutions for data quality and related concepts.

The speakers will share key lessons learned on the importance of adopting a strategy for ‘quality’. These include product workflow processes and UDI implementations that will help shape US and global UDI approach:

  • What is the impact of the US Food and Drug Administration (FDA) Quality System Regulation (QSR) transition to ISO 13485?
  • What role does UDI data play in the QMS?
  • Collaborative events in the supply chain and product data importance
  • Building quality into the product workflow — reducing cost, improving time to market
  • Planning UDI and quality strategy for the US (and global) market
  • Where to get guidance

Join this webinar to learn why implementing medical device QMS with downstream processes is critical for success.

Speakers

http://Gary%20Saner,%20Reed%20Tech

Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech

Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.

Message Presenter
http://Terrie%20Reed,%20Symmetric%20Health%20Solutions

Terrie Reed, Chief Strategy Officer, Symmetric Health Solutions

Terri Reed is Chief Strategy Officer at Symmetric Health Solutions. In her role at Symmetric, Ms. Reed continues to advocate and influence UDI adoption and influence the domestic and global implementation of device data standards. Terrie formerly led the Unique Device Identification Program as FDA CDRH Associate Director of Informatics and oversaw the inclusion of UDI in Health IT standards (X12, HL7, IEEE) and federal regulations. She is excited to transform how master device data is used across healthcare.

Message Presenter
http://Ben%20Bancroft,%20Greenlight%20Guru

Ben Bancroft, Medical Device Guru at Greenlight Guru

Ben is an experienced Quality Systems professional in the Medical Device Industry, specializing in compliance activities such as audits, CAPA, NCR and Deviations, currently a holder of ISO13485:2016 Lead Auditor Qualification. His prior chemical background focused primarily on medical and organic based chemical products.

Message Presenter
http://Mark%20Wasmuth,%20GMDN%20Agency

Mark Wasmuth, CEO, GMDN Agency

Mark provides leadership for the Global Medical Device Nomenclature (GMDN) Agency, serving health authorities, health care providers, manufacturers and others with a universal naming system used to exchange medical device information and support patient safety.

Message Presenter
http://Rich%20Kucera,%20Symmetric%20Health%20Solutions

Rich Kucera, CEO and President, Symmetric Health Solutions

Mr. Kucera is CEO and a co-founder of Symmetric Health Solutions, a healthcare supply-chain data aggregation, cleansing, and enablement company with products used by over 600 hospitals. He specializes in healthcare provider back-office data management, analytics, procurement, and inventory management.

Before Symmetric, Mr. Kucera led business-transformation and analytics teams at hospitals as a Manager in Accenture’s Health and Public Services practice. During this time, he analyzed procurement data for thousands of hospitals, both across US and overseas. Unable to meet the data needs of both downstream data consumers and of executives with the current industry tools, Mr. Kucera co-founded Symmetric with a focus on regulatory standards.

Mr. Kucera leverages his understanding of healthcare supply data chain to lead Symmetric in solving the ongoing challenges facing the industry today.

Message Presenter

Who Should Attend?

  • Regulatory Affairs/Operation Leaders
  • Product Managers and Business Analysts
  • Manufacturing, Operations and Supply Chain Leaders
  • Quality Leaders
  • IT Support

What You Will Learn

This webinar will be a helpful walk-through of the main takeaways in the published information from the US Food and Drug Administration (FDA) and experienced guidance from the Unique Device Identification (UDI) ‘go-to’ specialists. It is for regulatory teams working on the 2022 US FDA Class I UDI compliance and/or EU EUDAMED (European database on medical devices) and health authorities.

Xtalks Partner

Reed Tech

Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.

Life Sciences Solutions Driven by Accuracy and Insight

Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.

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