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Omnify Software håller ett Webinar om att förbereda sig för ISO 13485: 2016 Compliance

Torsdag 9 augusti 2018

ISO 13485: 2016 is the quality management backbone for many medical device manufacturers. This standard has recently been revised, with significant updates to the requirements. The new version was published in March 2016 and companies must complete their transition by March 31, 2019.
This complimentary, educational webinar taking place on September 6, 2018, will provide an overview of the updates made to the requirements and best practices for staying in compliance. This webinar will cover:
  • Regulatory Requirements: a brief overview of why we are where we are
  • Significant changes introduced in ISO 13485:2016
  • Using a Product Lifecycle Management (PLM) system to integrate risk and applicable regulatory requirements
Product Development, Quality, Engineering and Compliance Managers at medical device companies will benefit from attending this webinar.
WHEN: Date: Thursday September 6, 2018 at 1:00 pm ET (10:00 am PT) / Duration: 45 minutes (including questions and answers)
WHERE: Event will be presented online; those interested in attending this event can register for free online.
WHO: Hosted by Omnify Software, www.omnifysoft.com, with guest speaker Annette Schaps, CEO, Schaps Consulting. Annette is a bay area medical device quality and regulatory consultant with over 25 years of experience in small start-ups to large Fortune 500 organizations. She provides consulting services, is a subcontract Lead Auditor (MDSAP, EN ISO 13485:2016 and ISO 9001:2015) and Technical Expert (sterilization) for a Notified Body. She has a BS in Chemical Engineering and is a Certified Quality Engineer, Reliability Engineer, RAC, and ISO 27001 Information Security Lead Auditor.