Virtual Panel: Medical Device Identification

Recorded on June 16, 2020 | 11 AM EDT | 4 PM London

How Medical Device Classification and Identification Impact the Device Life Cycle

https://go.reedtech.com/hubfs/LS%20-%20NavMD/Virtual%20Meeting.mp4

View the recording

The lifecycle of a medical device can last years, even decades, encompassing everything from initial design and approval to maintenance, recalls and decommissioning. Very early in the lifecycle,  it is important to start thinking about how the device will be classified and if it will differ depending on the regulatory agency.

Device classification can take many forms such as device type described by FDA Product Codes and the Global Medical Device Nomenclature (GMDN) to broader descriptions like the medical specialty, device class and whether the device is implantable or sterile.

Beyond gaining regulatory approval or clearance, understanding a device's classification and unique identification can help with competitive intelligence, risk management, device tracking and quality management.

Agenda to include:

  • When in the device lifecycle to start the classification process
  • Available product classification lists and hierarchies: FDA Pro-Codes GMDN & more
  • Impact of UDI on the medical device lifecycle
  • How to leverage product classification for competitive and regulatory intelligence

Who should attend:

  • Regulatory Affairs Analysts and Leaders
  • Quality Analysts and Leaders
  • Post-market Surveillance and Risk Managers
  • Product Development, Business Development Analysts and Consultants

 

 

Speakers

TomRish-GG

Tom Rish - Medical Device Guru, Greenlight Guru 

Tom Rish is a Medical Device Guru at Greenlight Guru who works with customers to utilize their QMS software to build safer products on expedited timelines. He is a biomedical engineer who began his career developing implant and instrument systems in the orthopedic industry. He enjoys helping medical device companies successfully navigate regulations across global markets as they bring life changing technologies to market. 

Learn more - For a personalized demo of QMS software for medical devices: letschat@greenlightguru.guru +1-317-960-4220 

rachel_benway

Rachel Benway - Product Manager, Reed Tech

Rachel is an experienced Product Manager, leading the continuing development of Reed Tech Navigator for Medical Devices. She is skilled in managing database projects, requirements, technical product demos, and agile methodologies.

Learn more - email us at MedDevice@ReedTech.com

John_Lorenc

John Lorenc - Senior Manger Regulatory Solutions, Reed Tech

John directs electronic submission and regulatory requirement initiatives that impact both the medical device and pharmaceutical industries. He has advanced experience with electronic drug product labeling and listing requirements, and global Unique Device Identification (UDI) submissions. He participated as an industry resource in the original FDA pilot in 2012 and is currently focused on the present day requirements for EU UDI and South Korea and China. He represents Reed Tech in membership with MedTech Europe.

Learn more - email us at MedDevice@ReedTech.com

Mark Wasmuth GMDN

Mark Wasmuth - CEO, The GMDN Agency

The Global Medical Device Nomenclature (GMDN) is a list of generic names used to identify all medical device products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The main purpose of the GMDN is to provide health authorities and regulators, health care providers, manufacturers and others with a naming system that can be used to exchange medical device information and support patient safety.
The GMDN is used for:
• Data exchange between manufacturers, regulators and healthcare authorities
• Exchange and analysis of market surveillance and vigilance information
• Supporting inventory control in hospitals
• Purchasing and supply chain management

Learn more - GMDNagency.org