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      Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements in Fremont


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      April 4, 2019

      Thursday  10:00 AM - 11:00 AM

      Fremont, California, United States
      Fremont, California

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      EVENT DETAILS
      Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

      Overview
      This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

      Why should you Attend
      Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility.

      Failure to prove sterility is almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be re-sterilized by the user facility, cleaning and sterilization instructions must be precise and validated. Much attention has been paid to the regulatory requirements of reprocessing single use devices.

      However, there is increasing attention being directed towards reprocessing reusable medical devices and regulatory requirements.

      The purpose of this webinar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.

      Areas Covered in the Session
      Reasoning behind labeling requirements
      Regulatory requirements
      Intended use and design
      Standards/guidance
      Validating cleaning and sterilization
      Who Will Benefit
      Design Engineers
      QA Managers
      Quality Engineers
      Regulatory Affairs Managers
      Manufacturing Engineers
      Hospital Operating Room Nurse Supervisors
      Speaker Profile
      John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance experience and over 15 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking.

      Cost: Payment required - $150. One Attendee

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.