Why Medical Device QMS and UDI Data Quality Matters

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 Record (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

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.

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Terrie Reed, Director of Partnerships, Symmetric Health Solutions

Terrie is a former US Food and Drug Administration (FDA) CDRH Associate Director of Informatics and led the Unique Device Identification Program, overseeing the inclusion of UDI in Health IT standards (X12, HL7, IEEE) and federal regulations.

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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.

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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.

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