Medical Device Quality Systems

Quality System

Searching out improvements in quality, though valued, is often neglected during the development process due to weak quality controls. A focus on production without a stringent Quality Management System that goes beyond standard protocols may adversely affect the reputation of a firm and its ability to perform, whether that means decreased consumer confidence, compliance issues, corrective actions by the FDA/EU, or insolvency.

Since 1997, the FDA has taken strides to revolutionize the implementation of quality systems by creating the Quality System Regulation standards—standards that Sterling has followed since our founding. Our FDA compliant processes provide clients guidance through complexity to achieve a successful medical device that sets the bar for high quality in the industry.

Medical Device Quality Systems and Gap Analysis

Sterling’s gap analysis is a comprehensive method of looking at every level of management in a medical device quality system to effectively allocate resources. Risk analysis is utilized in conjunction with medical device quality system management for a safe, reliable, and repeatable process. The “gap” aspect is when the comparison of previous standards and ideal future standards are reviewed. The goal is to bridge that gap to translate ideas into reality. Sterling’s in-depth experience in the modern medical device field becomes a substantially beneficial factor to gap analysis. Historical evidence is researched as well as assessed to align with Part 11 & HIPAA requirements. Quantifiable standards that streamline development procedures help identify critical areas in your system.

An Outlook of Dedication

Sterling’s role in independent auditing gives you the flexibility to work with a medical device quality system that is optimized for your needs. Whether it’s creating a medical device quality system from scratch with our team, remediation and reconstruction of an existing one, or relying on one of our own formulated quality systems, Sterling considers quality a serious component to product development and remains flexible in its approach. Our team offers medical device quality consulting and has the patience and proactive mindset to resolve issues swiftly, whereby client needs are prioritized, and waste is reduced. Medical devices should not only fulfill uniform quality framework standards, but efficiently maintain quality throughout its existence in the ecosystem.

With our familiarity of medical device quality assurance and regulatory compliance, Sterling helps relieve excessive regulatory burden. At times during the process, FDA roadblocks may delay quality approval without a clear means of how complications can be solved. Sterling not only pinpoints quality errors, but also provides the knowledge to improve the device, the system, and/or the development process. Official quality assurance by auditors improves brand reputation in the industry as a whole—for the audience and investors alike—by highlighting to users that the product excels in its purpose.

For more information on our medical device quality system, schedule a consultation with our team today.

Resources

October 9, 2014

5 Mistakes Medical Device Startup Companies Need to Avoid

The path through the FDA approval process to market may seem perilous, but avoid these five common mistakes, follow advice from Sterling’s Bruce Swope and Erik Hilliard, and your medical device...
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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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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

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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