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Tag: Medical Device Academy

Test Plan Webinar

Medical Devices
In this webinar, you will learn how to prepare a verification and validation test plan for your 510(k) or De Novo submission. Your cart is...

Top News

Predicate selection guidance proposes controversial additions

Medical Devices
The FDA released a new draft 510k predicate selection guidance on September 7, but the draft guidance proposes controversial additions. On September 7, 2023, a...

Design Controls Implementation

Medical Devices
Posted by Rob Packard on August 30, 2023 Design controls can be overwhelming, but you can learn the process using this step-by-step...

CAPA – Corrective Action and Preventative Action

Medical Devices
Posted by Rob Packard on July 18, 2023 What is a CAPA? How do you evaluate the need to open a new...

FDA US Agent – What do they do?

Medical Devices
Posted by Rob Packard on May 9, 2023 Medical device companies exporting devices into the USA must have a US agent to...

FDA US Agent – What do they do?

Medical Devices
Posted by Rob Packard on May 9, 2023 Medical device companies exporting devices into the USA must have a US agent to...

OpenAI and Elsmar never trust their help with regulatory questions?

Medical Devices
Posted by Rob Packard on April 4, 2023 Everyone has a favorite resource they use to answer regulatory questions, but can you...

How quickly will RTA policy take effect for cybersecurity devices?

Medical Devices
Posted by Rob Packard on March 29, 2023 Breaking news! The FDA just released new guidance on the refusal to accept...

Nine easy ways to organize and improve quality system procedures

Medical Devices
Posted by Rob Packard on March 28, 2023 Would you like to learn nine ways to improve your quality system procedures? One...

How to select and help validate the best sterilization method?

Medical Devices
Posted by Rob Packard on February 7, 2023 The FDA eSTAR includes a list of eight different options for a sterilization method,...

UDI Procedure and UDI Requirements

Medical Devices
Posted by Matthew Walker on November 18, 2022 Learn how to create a UDI procedure for compliance with the FDA and EU...

Monitoring Congestive Heart Failure Through Speech: Interview with Tamir Tal, CEO of Cordio Medical

Medical Devices

Medical Devices and Their Environmental Impact

Medical Devices
Climate change is a persistent and important issue globally. Many countries and companies are trying their best to implement policies that will combat the...
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