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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Document Management Training Management CAPA Management Audit Management Product Development

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Posts by Laura Court

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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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

Your Device is Non-Significant Risk: Now What?

Laura Court
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?

Laura Court
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

Laura Court
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

Laura Court
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?

Laura Court
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
Product Development

How are Medical Devices Classified under EU MDR?

Laura Court
July 23, 2021
One of the most important steps in bringing a medical device to market in the European Union (EU) is determining the correct classification for your device. Read More

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