Helping clients develop devices the right way.

GMP/QSR/ISO Review

All the work we do adheres to stringent guidelines in order to ensure your project is done correctly and timely. These guidelines are Good Manufacturing Practices, Quality System Regulation, and ISO standards.

• Consulting to help streamline workflows of your Quality System
• Quality System Review and Gap Analysis
• Develop and Implement a remediation plan
• Solving manufacturing system problems in a GMP compliant manner
• Proven track record of FDA/CE approvals

Sterling Medical Devices has decades of experience helping clients develop devices the right way! We understand that Quality Systems and how they are practiced are very important in the process of Medical Device Development and ultimately in obtaining medical regulatory compliance. That is why all the work we do adheres to stringent guidelines in order to ensure your project is done correctly and in a timely fashion. These guidelines are Good Manufacturing Practices, Quality System Regulation, and ISO standards. These practices and guidelines are followed through many of the stages of the device’s life-cycle and if not could lead to a costly redesign that will also delay your device from reaching the market.