QMS Design, Implementation, & Training

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Author: Sterling Medical Devices | April 28, 2022

QMS Design, Implementation, & Training

Need help implementing a Quality Management System?Are you struggling to develop and implement a Quality Management System (QMS)? Looking for a comprehensive solution that can streamline the process...

Author: Sterling Medical Devices | April 26, 2022

Medical Device Quality Systems

Author: Sterling Medical Devices | April 26, 2022

Pre-Market Clearance and Approval

Accelerate Your Product's Time-To-Market With Our Experts!The submission process is a tedious and lengthy endeavor. It is critical to understand the FDA's expectations for a premarket submission....

Author: Sterling Medical Devices | April 25, 2022

QMS Compliance and Remediation

QMS Compliance and Remediation - We've got you covered!Failure to meet regulatory standards can lead to product recalls, fines, and reputation damage that can put a strain on your resources and...

Author: Sterling Medical Devices | April 25, 2022

Regulatory Strategy Support

Defining Your Regulatory Strategy Is KeyOur team has decades of experience helping medical device companies make sense of global regulatory landscapes in countries and regions all over the world....

Author: Sterling Medical Devices | April 22, 2022

FDA Post-Market Surveillance

Stay compliant in any market. Unload the burden of post-market surveillance activities to the experts!We offer full-service Post-Market Surveillance (PMS) planning and execution for all markets, for...

Author: Sterling Medical Devices | April 20, 2022

Device Classification

Classify Your Device CorrectlyGetting the classification wrong can have serious consequences for your budget and timeline. It's important to do your research and work with experts to ensure you're...

Author: Sterling Medical Devices | April 20, 2022

QMS Auditing

Ensure Your QMS Meets Required StandardsOur audit services help take the stress and worry out of QMS audits. Offering both on-site and remote QMS audit services, we’ll help you maintain...

Author: Sterling Medical Devices | August 6, 2021

Medical Device Industrial Design

To be successful, your medical device product must do its job well, be user-friendly, and be manufactured cost efficiently. Sterling Medical Devices’ experts offer industrial design consultations...

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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QMS Design, Implementation, & Training