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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.

Product Development

Ultimate Guide to Device Class Requirements under EU MDR

December 11, 2022
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Product Development

MDCG 2020-5 Explained: How To Demonstrate Equivalency in the EU

October 9, 2022
MDCG 2020-5 is a guidance document put out by the European Commission (EC) to clarify the process for demonstrating equivalence with another CE marked medical device.  Read More
Product Development

MDCG 2020-6 Explained: Sufficient Clinical Evidence for Legacy Medical Devices in the EU

September 9, 2022
When EU MDR entered into force on May 26, 2017, it raised the bar for what constitutes sufficient clinical evidence to demonstrate a device’s conformity with EU regulations. Read More
Product Development

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

September 1, 2022
When it comes to complexity, medical devices run the gamut. Read More
Product Development

How To Apply a Risk-Based Approach to Biological Evaluation

July 1, 2022
No matter where you plan on marketing your medical device, you’ll be required to perform a biological evaluation on your device before you receive regulatory approval. Read More
Product Development

Applying for International Patents as a Medical Device Company

June 3, 2022
Obtaining a patent (or patents) for your medical device is the best way to protect your intellectual property from being used by competitors. Read More
Product Development

8 Questions That Define Your Medical Device User Needs

May 6, 2022
When people talk about design controls, they often place a lot of emphasis on design inputs and outputs, verification, transfer, and the design history file. Read More
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

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