Quality Management system is essential for well functioning medial device company. We strive to meet all the requirements as per the standards and regulations. We ensure our clients meet all the ISO, MDSAP, CE and FDA QMS requirements. We understand that the cornerstone of any quality improvement program is sustainability. Our programs engage your leadership and teams at all levels to ensure the proper control processes are in place to maintain quality across development, manufacturing, and distribution of your product. Our Quality Practice includes: 

Quality Management Services

• Quality Systems Development
• Data Integrity
• Quality IT Systems
• Quality Remediation
• Management Controls
• Risk Management
• Design Controls
• Train and Qualify Staff
• New/Revised Standards & Regulations
• Management Review
• Validation & Qualification
• Risk Management
• Laboratory Controls
• Batch Review
• Quality Engineering
• Exceptions
• Post Market Surveillance

Through comprehensive quality consulting, we have empowered thousands of customers to efficiently navigate the life science product lifecycle from end to end.