ISO 13485 for Medical Devices and Equipment

February 25, 2024
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Medical device manufacturing is among the most regulated sectors, demanding strict adherence to quality systems and product standards. These regulations aim to guarantee that manufacturers consistently develop, produce, and distribute medical devices that meet safety standards and fulfill their intended functions.

ISO 13485 provides a framework for implementing and maintaining a comprehensive quality management system tailored to the specific needs of the medical device industry.

During the upcoming webinar, CMTC experts Eliot Dratch and Lynn Zhao will discuss:

  • The benefits of ISO 13485 certification
  • ISO 13485 certification requirements
  • Similarities and differences among ISO 13485, ISO 9001, FDA 21 CFR 820, MDSAP, & cGMP
  • Resources available to help manufacturers achieve ISO 13485 certification & other industry accreditations