At Accent-TS, our commitment to designing, developing, and servicing medical devices is rooted in patient safety and regulatory compliance. We are proud to be ISO 13485 certified, the world’s most recognized Quality Management System (QMS) specifically for the Medical Device Industry.
This certification is more than a badge; it is a life-saving commitment rooted in performance, risk mitigation, and stringent adherence to regulatory requirements, ensuring that every medical device interaction meets the highest standards of safety and effectiveness.
What ISO 13485 Means for Our Clients and Users:
- Safety and Efficacy Assured: You can rely on us. Our certified processes provide absolute confidence that every device or component we handle is manufactured and serviced under controls specifically designed to protect patients and ensure the product performs as intended.
- Regulatory Compliance Built-In: The core of our QMS is compliance. We have structured processes for meeting global regulatory requirements (such as CE marking and FDA demands), minimizing regulatory risk for our clients and facilitating faster market access.
- Full Traceability and Risk Management: We adhere to strict procedures for risk management throughout the entire product lifecycle, from design to post-market surveillance. This ensures complete traceability of materials and components, which is critical for effective field safety and rapid recall actions.
The Foundation of Our Medical Device Excellence:
Achieving ISO 13485 certification requires a rigorous, continuous commitment to:
- Design Control: We implement documented procedures to ensure that device design and development output meet user needs and intended uses, with formal verification and validation checkpoints.
- Supplier Control: We strictly evaluate and monitor suppliers of critical components to ensure the quality and purity of incoming materials, which is paramount for device reliability.
- Corrective and Preventive Action (CAPA): We maintain a robust system for investigating nonconformities, complaints, and adverse events, ensuring timely and effective actions are taken to prevent recurrence and enhance patient safety.
