Navigating Regulatory Complexities ~ Medical Device Industry
Webinar via Zoom ~ Join us for an insightful presentation on navigating regulatory complexities in the medical device industry with Anne Arndt, Senior Regulatory Consultant and CEO of the Johner Institute New Zealand. Many companies and investors are caught off guard by the vastly different regulatory requirements that apply to the same product, depending on whether it is marketed as a medical device. These unexpected hurdles can lead to unnecessary costs, prolonged development times, and unwelcome surprises during the authorisation process.
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Join our upcoming webinar hosted by LESANZ NZ!
In this talk, Anne will demystify the regulatory landscape, outlining the specific requirements for medical devices and sharing insights into proven strategies for a successful market launch. Learn how to avoid common pitfalls and streamline your path to market with expert guidance and strategic planning.
Date: Wednesday, 21st August
Time: 1 PM NZT or 11AM AEST
BY: Zoom - LESANZ Members complimentary | Non members $25 incl of GST
Presenter: Anne Arndt | Director Johner Institute New Zealand Ltd. | Regulatory Consultant | Software as a Medical Device (SaMD) Expert | SaMD Expert Witness
Did you know that two identical products can face vastly different regulatory landscapes depending on their declared use? Take, for instance, a simple absorbent pad: whether it’s labelled as a baby diaper or an incontinence pad for adults can result in a regulatory journey that varies by years, requiring different studies and approval processes. And when you consider launching such a product in multiple countries, the complexity grows exponentially.
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