QMS Compliance and Remediation

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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 disrupt business operations. If you need help implementing a new QMS, maintaining compliance, or require remediation due to audit findings, a recall, or an FDA Form 438 or Warning Letter, we can help.

QMS compliance services:

QMS implementation
Full or partial internal audits
Pre-assessment audits
Gap analysis
Transition support

QMS remediation services:

Nonconformance remediation
FMEA or fault tree investigations
CAPA procedures
FDA Form 483 (Inspectional Observations) and FDA Warning Letter response
Nonconformance management procedure implementation to address deficiencies
Field questions from you or the FDA during corrective action activities

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Let us take the headache out of QMS compliance and remediation. Leverage our decades of experience and our ISO 13485-certified QMS system. Contact us today for a free consultation.

About Sterling Medical Devices

Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.

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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.

Interested in learning more about how we can work together in your current or next medical device design project?

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QMS Compliance and Remediation