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

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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 Helene Quie

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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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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About the Author

Helene Quie has a degree in Science specialised within Cell Biology from the University of Odense, Denmark. Helene has more than 25 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S. Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access and general management. In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.

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Regulatory Submission

Navigating Clinical Evaluations and Investigations in MedTech

Helene Quie
January 12, 2024
In an era where technological advancements and regulatory requirements are constantly evolving, the MedTech industry faces the critical challenge of enhancing both safety and... Read More

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