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Laura Court

Laura Court
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.

Author's Posts

8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about design controls, they often place a lot of emphasis on design inputs and outp...
Understanding Technical Documentation in EU Regulations - Featured Image

Understanding Technical Documentation in EU Regulations

Generally speaking, technical documentation is the compilation of documents that explains how a prod...
Your Device is Non-Significant Risk: Now What? - Featured Image

Your Device is Non-Significant Risk: Now What?

If you need to conduct a clinical investigation of your device before it has received market approva...
Bill of Materials (BOM) for Medical Devices: Everything You Need To Know - Featured Image

Bill of Materials (BOM) for Medical Devices: Everything You Need To Know

When it comes to complexity, medical devices run the gamut.
What Does the IDE Application Process Involve? - Featured Image

What Does the IDE Application Process Involve?

When medical device manufacturers hope to bring a new and perhaps revolutionary medical device to ma...
ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices - Featured Image

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

For many medical devices, sterilization is the final step in the manufacturing process before they’r...
ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide - Featured Image

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

Once a medical device has been designed, developed, and manufactured to specifications, it may feel ...
What’s the Difference Between Clinical Evaluation and Clinical Investigation? - Featured Image

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

Within the myriad of regulations and standards governing medical devices, there are a number of simi...
What is the FDA Medical Device Registration Process? - Featured Image

What is the FDA Medical Device Registration Process?

To patients and providers, medical devices are more than a product. They serve as the conduit to bet...
How are Medical Devices Classified under EU MDR? - Featured Image

How are Medical Devices Classified under EU MDR?

One of the most important steps in bringing a medical device to market in the European Union (EU) is...
Does My Device Labeling Comply with 21 CFR 801? - Featured Image

Does My Device Labeling Comply with 21 CFR 801?

Medical device labeling is a core requirement for getting your device onto the market.
What is 21 CFR 812 - Investigational Device Exemption? - Featured Image

What is 21 CFR 812 - Investigational Device Exemption?

Could your medical device qualify for an investigational device exemption (IDE)?

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