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7 FDA Pathways to Bring Your Medical Device to Market - Featured Image

7 FDA Pathways to Bring Your Medical Device to Market

Anyone reading this who is planning to launch a medical device in the U.S. has likely heard of the 5...
2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020 - Featured Image

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for...
Medical Device Classification Guide - How To Determine Your Device Class - Featured Image

Medical Device Classification Guide - How To Determine Your Device Class

What I am about to share with you is a guide to medical device regulatory classification.
Navigating the Twists and Turns of Change Management for Medical Devices - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

Change is constant… Especially in the medical device industry. Medical device change management can ...
What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers? - Featured Image

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...
Complete Guide to Bringing a Medical Device to Market - Featured Image

Complete Guide to Bringing a Medical Device to Market

Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...
Ultimate Guide to Agile Design and Development for Medical Devices - Featured Image

Ultimate Guide to Agile Design and Development for Medical Devices

                                Table of Contents   Overview - Agile Design and Development for Medi...
Biocompatibility Nuances and its Impact on Medical Devices - Featured Image

Biocompatibility Nuances and its Impact on Medical Devices

Biocompatibility can be challenging and frustrating when developing a medical device. Why do you hav...
How to Write Effective SOPs for Medical Devices - Featured Image

How to Write Effective SOPs for Medical Devices

Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...
Top 50 Medical Device Product Design and Development Companies - Featured Image

Top 50 Medical Device Product Design and Development Companies

Medical device companies have to overcome many significant challenges when bringing a new product to...

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