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About the Author

Laura Court is a Medical Device Guru and Mechanical Engineer who loves learning about new technology and sharing her experiences with others. She has experience in New Product Development and Manufacturing with both small and large companies. Having managed products through their full product lifecycle into post market support, Laura understands the amount of work required to build out all the documentation required for regulatory approval and support. Her knowledge, experience and passion with medical devices is evenly matched with how much she enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

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Product Development

Understanding Technical Documentation in EU Regulations

March 13, 2022
Generally speaking, technical documentation is the compilation of documents that explains how a product is designed, its intended use, and other relevant information. The... Read More
Product Development

Your Device is Non-Significant Risk: Now What?

February 27, 2022
If you need to conduct a clinical investigation of your device before it has received market approval, then you’ve probably found yourself looking through the FDA’s guidance... Read More
Product Development

What Does the IDE Application Process Involve?

December 9, 2021
When medical device manufacturers hope to bring a new and perhaps revolutionary medical device to market, they face a dilemma. A device that may have the chance to improve... Read More
Product Development

ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices

December 3, 2021
For many medical devices, sterilization is the final step in the manufacturing process before they’re shipped and used by patients and providers all over the world. Read More
Product Development

ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide

November 16, 2021
Once a medical device has been designed, developed, and manufactured to specifications, it may feel as though a major bridge has been crossed. Soon, the device will be in the... Read More
Clinical Data Collection

What’s the Difference Between Clinical Evaluation and Clinical Investigation?

October 26, 2021
Within the myriad of regulations and standards governing medical devices, there are a number of similar terms that tend to be used interchangeably within the industry, even... Read More

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