The Webinar Wednesday presentation “Practical Applications of ISO 13485 and What It Means for HTM Professionals” was sponsored by Innovatus Imaging. Attendees are eligible to receive 1 credit from the ACI.
Dennis Wulf’s insightful presentation drew a crowd with 149 people tuning in for the live presentation, including at least one individual in Thailand. A recording of the webinar is also available online where even more people can access the material.
Wulf, founder of Innovatus Imaging, presented a working understanding of what this quality certification means. He discussed why it matters for health care facilities and what to expect from repair providers that are ISO 13485 certified. He also spoke about those organizations that do not have the quality certification.
Thanks to his more than 35 years of experience working with medical devices specializing in ultrasound, Wulf was able to provide valuable knowledge and advice.
Attendees shared feedback via a post-webinar survey that included the question “How will today’s webinar help you to improve in your role?”
“(The webinar) helped to put a new perspective on quality metrics. It had a big push for using the metrics to try and be the best organization you can be as opposed to just meeting the metrics because they are required,” Biomedical Engineer D. Nitinthorn said.
“Informative as it provided guidelines for both management and technical matters,” Biomedical Engineer E. Gonzales shared.
“At the present, we are certified ISO 9001:2015. We plan to certify ISO13485 in 2020-2021 to have more a competitive advantage for HTM industries in Thailand. When I attended today’s webinar it helped me have a better understanding what ISO 13485 is, not only the medical manufacturer but being able to apply to a service firm as well,” said P. Indrambarya, HR & QMS Manager, Thailand.
“The speaker’s experience and expertise in the market sector will help in our planned addition of ISO 13485 to our current ISO 9001,” said S. Cushing, Quality Manager.
“Dennis presented outstanding information very relevant to the field. The topic is timely and I hope many of my peers are paying attention to Dennis’ subject matter,” Senior Director C. Nowak said.
“The more information I can get on anything medical-equipment related will always help me to become better at my job,” said J. McAlister, Program Director.
“I will be using this content to help me understand the differences between ISO 9001 and 13485. I will also use the terminology to develop more concise policies and procedures,” said L. Robert, Associate Director.
“I will strive to use what I’ve learned here to make my department a quality-driven organization,” said F. McVean, Business Process Manager.
“We are in the process of ISO certification and it was good to hear other people’s perspectives on it and how long it roughly took till completion from the speaker,” said P. Byrne, Sales Director.
The session pushed the 2019 Webinar Wednesday Series past the 7,000 attendee mark. For information about the series and upcoming presentations, visit WebinarWednesday.Live.
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