Quality Management & Compliance

Empowering Excellence, Efficiently

We take pride in implementing quality management systems (QMS) that enable efficient execution of the required processes. Our quality experts understand how to address each span of the product life cycle, from development through manufacturing and modifications.

Top tasks we help with:

  • Implement Effective Systems: Establish streamlined quality management systems for product development, aligning with global regulatory standards.

  • Optimize Efficiency: Implement strategies to enhance efficiency in product development processes while maintaining compliance with global standards.

  • Ensure Regulatory Adherence: Rigorously adhere to regulations and requirements, considering international standards such as FDA, ISO, EU, and Health Canada.

  • Proactively Manage Risks: Take proactive measures to identify and manage risks throughout the development cycle, meeting industry expectations and global regulatory standards.

  • Monitor and Manage Suppliers: Vigilantly oversee suppliers to ensure consistent quality, aligning with regulatory expectations and global standards.

  • Rigorously Confirm Product Compliance: Employ rigorous processes to confirm products meet requirements and standards set by FDA, ISO, EU, and Health Canada.

  • Constantly Monitor Device Performance: Keep a vigilant check on device performance and customer feedback, adhering to global regulatory expectations.

Achieve peace of mind by partnering with Edaphy. We understand how to efficiently align your business with global quality standards like ISO and FDA regulations.