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Data collection and management designed for MedTech clinical trials.

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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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Product Development

Building Your Regulatory Strategy for Commercialization

Etienne Nichols
September 14, 2022
What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls... Read More
Product Development

AAMI TIR45: Closing the Gap Between Agile Software Development & Medical Device Regulations

Etienne Nichols
September 11, 2022
In 2012, the Association for the Advancement of Medical Instrumentation (AAMI) released the technical report AAMI TIR45 - Guidance on the use of AGILE practices in the... Read More
Product Development

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

Laura Court
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

Packaging Validation Best Practices

Etienne Nichols
September 7, 2022
The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling... Read More
Product Development

Explaining MDCG 2019-11: Software Qualification & Classification for MDR & IVDR

Tom Rish
September 2, 2022
Medical device software (MDSW) in the European Union is regulated by the European Commission (EC) via EU MDR and EU IVDR, and the classification rules for MDSW can be found... Read More
Product Development

Overcoming Submission Deficiencies due to Biocompatibility

Etienne Nichols
August 31, 2022
What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance? Read More
Product Development

Understanding FDA’s Special 510(k) Program

Etienne Nichols
August 28, 2022
They say the only constant in this life is change. Whoever first said it may very well have been discussing medical devices. Read More
Product Development

How to Communicate Your Regulatory Strategy to Medical Device Investors

Etienne Nichols
August 26, 2022
In the medical device industry, the regulatory pathway you choose will determine the amount of money and time you need to get your device on the market. Generally speaking,... Read More
Product Development

Does Your CAPA Process Need a CAPA?

Etienne Nichols
August 24, 2022
Have you done Corrective and Preventive Actions (CAPA) on your CAPA process? If not, you need to seriously consider doing so because CAPA is the #1 reason why companies get... Read More

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