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About the Author

Niki Price is a Medical Device Guru who has spent her entire career working with different types of medical devices. She began her journey in production, which is where she discovered how important and fulfilling this line of work was to her! Spending time in both Quality and R&D, she enjoys the product development process and witnessing great results as a product of great design. Niki hopes to continue to her journey by helping others build quality into their products and processes.

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Product Development

What is the Best Way to Structure a Risk Management File?

May 14, 2023
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
Product Development

eBOM vs mBOM: What’s the Difference?

March 31, 2023
A bill of materials (BOM) contains all the materials and parts required to build your device, as well as directions for how to use them and where to acquire them. Read More
Product Development

Making the BOM & Design Controls Connection

March 19, 2023
Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More
Clinical Data Collection

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

April 15, 2022
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Establishing a QMS

How to Create a Clinical Evaluation Report (CER) under MEDDEV & MDR (Part 4 of 4)

April 3, 2022
If you plan on selling a medical device in the European Union, then you should plan on writing a clinical evaluation report (CER). Your CER will document the clinical... Read More
Product Development

Performing Data Analysis for Your Medical Device’s Clinical Evaluation (Part 3 of 4)

April 1, 2022
All of your hard work has been leading up to this. So far in the clinical evaluation process, you’ve made a plan, gathered clinical data, and appraised its relevance and... Read More
MedTech Lifecycle Excellence

The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4)

March 25, 2022
A successful clinical evaluation hinges on your ability to find and appraise the data you’ll need to demonstrate your device’s safety and performance. Read More
Product Development

Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4)

March 20, 2022
To obtain a CE marking and market your medical device in the EU, you’ll first need to perform a clinical evaluation—and report your findings in a Clinical Evaluation Report... Read More

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