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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 Niki Price

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

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?

Niki Price
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?

Niki Price
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

Niki Price
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

Niki Price
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)

Niki Price
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)

Niki Price
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)

Niki Price
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)

Niki Price
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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