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Overcoming Challenges of Evolving Restrictions on Materials in Medical Devices

Thomas Bowles (Director of Quality Assurance, FUTEK Advanced Sensor Technology, Inc.)

Location: 210D

Date: Wednesday, February 6

Time: 8:30am - 9:15am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

As the RoHS, REACH, SVHC, and Conflict Materials regulations continue to evolve and pose new restrictions on medical device manufacturers, device makers must be cognizant of the changes so that their products remain compliant in every market. While the original RoHS directives apply in 28 EU countries, similar legislation has been implemented in China and is being pushed forward in Japan, South Korea, Norway, Turkey, and Singapore. REACH regulations add new restricted substances and publish new lists every six months.

Topics covered include:
  • Applications of these standards to miniaturized medical devices requiring more exotic materials to meet demands of similar stationary equipment
  • What designers must be cognizant of with regard to restrictions
  • Implementation deadlines to meet EU MDR guidelines

Presentation File

Overcoming_Challenges_of_Evolving_Restrictions_on_Materials_in_Medical_Devices.pptx