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Design History File Remediation DHF Remediation

Ablation Controller

An early stage medical device company had a need for Design History Remediation for a controller which was developed outside of design controls....
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Development DHF Remediation

Catheter System

A medical device company purchased catheter products from another company and needed DHF documents reviewed/updated to meet quality system requirements....
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Resources

Alarm clock next to laptop on desk with bar graphs on screen

August 9, 2022

Using Regulatory Strategy to Reduce Medical Device Time to Market

Using Regulatory Strategy to Reduce Medical Device Time to Market According to recent estimates (1), the global medical device market is expected to grow from over $455 billion in 2021 to...
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5 Mistakes Medical Device Startups Make

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
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