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Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

May 16, 2023
Medical devices are intended to save and improve quality of life. Read More
Product Development

How To Vet Medical Device Distributors in Multiple Markets

May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More
Product Development

What is the Best Way to Structure a Risk Management File?

May 14, 2023
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
Establishing a QMS

Understanding ISO 14971 Medical Device Risk Management

May 11, 2023
Medical device companies MUST have established risk management processes that comply with ISO 14971. Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

May 11, 2023
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Establishing a QMS

5 Dos and Don'ts when Choosing a QMS Solution for Your Medical Device Company

May 10, 2023
As a medical device manufacturer, your quality management system (QMS) is the heart of your operations.  Read More
Product Development

How to use the SMART-TRIAL AE/SAE reporting module

May 8, 2023
This blog post highlights the ready-to-use SMART-TRIAL module for Adverse Events (AE) and Serious Adverse Events (SAE). Let’s dive into how the reporting module benefits... Read More
Product Development

Planning Your Medical Device Global Market Regulatory Strategy

May 5, 2023
A regulatory strategy is more than just picking a pathway to market. It’s an in-depth process by which you choose the best markets and pathways not only for your device, but... Read More
Product Development

Why Clinical Data Is Essential to Value-Based Healthcare

May 1, 2023
The healthcare industry in many countries is undergoing a transition. We’re moving away from a strict focus on the upfront cost of care to what’s known as “value-based”... Read More

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