FDA`s Regulation of Implantable and Wearable Sensors 2016

  • 06-07 Oct 2016
  • Boston, MA, United States

Description

FDA`s Regulation of Implantable and Wearable Sensors 2016 is a seminar that covers topics such as:

  • FDA regulatory approvals for sensors
    • FDA guidance documents for sensors
    • Currently approved sensors in medicine
    • How the FDA regulates sensors
    • Global approval of sensors
    • Sensors for both diagnostic and therapeutic purposes
    • The medical device, drug and biological approval process
    • Applicable good manufacturing and good laboratory practices
    • How to design appropriate clinical trials
    • FDA and other federal agency enforcement action
    • Product labeling, marketing and advertising
  • Fundamentals of sensors
    • How to build sensors
    • What is all the excitement about
    • Incorporating cells and/or biological materials into sensors
    • Wearable versus implantable sensors
    • Biological reactions to sensors
    • Avoiding immune system clearance of sensors
  • Future thoughts on approaches for the regulatory approval sensors
    • Outlook for new technologies
    • Remaining hurdles

FDA`s Regulation of Implantable and Wearable Sensors 2016 brings together:

  • Quality professionals
  • Senior quality managers
  • Compliance professionals
  • Regulatory professionals
  • Manufacturing engineers
  • Production supervisors
  • Design engineers
  • Production engineers
  • Contract manufacturers
  • Labelers and private labelers
  • U.S. agents of foreign corporations
  • Importers and custom agents
  • Quality engineers
  • Process owners
  • Document control specialists
  • Quality auditors
  • Medical affairs
  • Record retention specialists
  • Financial advisors and institutional investors
  • Legal professionals
  • Graduate students
  • Patent lawyers
  • Clinicians
  • Academic faculty and professors
  • Entrepreneurs

Past Events

Important

Please, check "FDA`s Regulation of Implantable and Wearable Sensors" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Finance, Internal Audit & Compliance, Legal, Management, Quality assurance
Health & Medicine: Healthcare, Pharma
Science: Life Sciences & Biology

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