DHF Remediation



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

Notes reading FDA recall signify the consequences of medical device failure

January 26, 2022

Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm

Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm By manufacturing and providing a medical device, you are taking on a big responsibility....
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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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Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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