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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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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.
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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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

5 Tips for Running Effective Internal Quality Audits

Etienne Nichols
March 31, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies. Read More
Product Development

How to Handle Medical Device Adverse Events

Etienne Nichols
March 24, 2023
Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More
Product Development

Explaining IVDR Classification for In Vitro Medical Devices

Wade Schroeder
March 23, 2023
What is IVDR? The In Vitro Diagnostic Regulation (IVDR) is a European Union regulation applicable to in vitro diagnostic medical devices. It establishes a risk-based... Read More
Product Development

Complete Guide to Bringing a Medical Device to Market

Tom Rish
March 20, 2023
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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
Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

Jon Speer
March 17, 2023
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Product Development

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Etienne Nichols
March 15, 2023
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Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols
March 13, 2023
The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More

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