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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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Product Development

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

Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?

Tom Rish
October 7, 2022
In September 2022, the FDA issued a draft guidance that marks a significant transition in the MedTech industry's approach to software validation. 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

Preparing for EUDAMED - Europe’s Medical Device Database

Taylor Brown
October 3, 2022
In 2017, the European Commission (EC) released two new regulations, one specific to medical devices and the other for in vitro diagnostic medical devices. 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

15 Steps to Getting Approval for IEC 60601-1

Jon Speer
September 26, 2022
Does your company have approval for IEC 60601-1? If you produce medical electrical equipment (MEE) or systems you soon will have to as this general standard applies to all... 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
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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