Quality and Regulatory Support

Dedicated Customer Teams & Agile Services

Our worldwide presence ensures the timeliness, cost efficiency compliance adherence required to ensure your production timelines are met.

Overview

We take pride as a medical device manufacturer with high performance standards through the implementation of stringent quality and regulatory processes. Our team operates within a defined Medical Device Quality Management System. With a detailed quality plan, operating procedures and parameters, and implementation, we operate within customers’ critical-to-quality (CTQ) requirements. We employ the necessary tools and processes to ensure functional verification, validation, and monitoring of production parameters.

Capabilities

We are committed quality ensures that our products and services meet applicable standards as per international regulatory bodies. We have implemented Medical Device Quality Management System that produces reliable and repeatable outcomes in product and processes. We assist our customers with agency approval process using certified third-party suppliers to demonstrate with evidence that there is reasonable assurance that the device or device system is safe and effective for its intended use. We continuously work to ensure that we meet all quality and regulatory requirements throughout your entire product life-cycle.
  • ISO 13485 Quality management system - Regulatory strategy development
  • Definition of intended use - Applicable standard identification
  • Quality plan and control - Verification and validation control
  • CE Mark submission support - Traceability document control
  • Risk Management -Supplier quality management