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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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Ideation & Prototyping

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

Common QMS Mistakes SaMD Companies Make

Etienne Nichols
October 20, 2022
What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Read More
Product Development

Design Assurance: The Unsung Heroes of R&D

Etienne Nichols
October 13, 2022
What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but... Read More
Product Development

Lessons from an Industry Leader: Playing the Long Game of MedTech

Etienne Nichols
October 6, 2022
What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you... Read More
Product Development

3 Tips For Incorporating Risk Management During Medical Device Product Development

Jon Speer
September 30, 2022
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these... Read More
Product Development

7 Common 510(k) Mistakes and How to Avoid Them

Etienne Nichols
September 28, 2022
The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of... Read More
Product Development

IEC 82304 vs IEC 62304: Software Standards for SaMD Explained

Etienne Nichols
September 23, 2022
IEC 82304-1 is one of many standards that medical device companies should use while developing software as a medical device (SaMD). It covers the requirements for... Read More
Ideation & Prototyping

Best Practices for Clinical Evidence Management

Etienne Nichols
September 22, 2022
How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process,... Read More
Product Development

What You Need to Know About Medical Device Software Validation

Etienne Nichols
September 18, 2022
Software is certainly not a new concept to the medical device world. Read More
Product Development

MEDDEV 2.7/1 Rev. 4 & MDCG Guidance: Carrying Out Clinical Evaluation Under EU MDR

Tom Rish
September 16, 2022
When regulatory bodies need to clarify or establish expectations regarding a part of their regulations, they put out guidance documents. Read More

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