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ISO 13485 – Medical Device Quality Management System

An internationally recognized quality management standard ensuring medical devices are safe, reliable, and compliant with regulatory requirements.

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ISO 13485 – Medical Device Quality Management System

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  1. ISO 13485 Standards Medical Device Quality Management System www.getisocertificate.com

  2. ISO 13485 is a globally recognized standard for quality management systems in the medical device industry. It establishes strict controls for design, development, production, storage, distribution, and servicing of medical devices. The core focus is patient safety, regulatory compliance, and consistent production of safe, effective medical products across all markets. Introduction

  3. Design & development controls • Risk management throughout lifecycle • Supplier quality control • Production validation & process controls • Complaint handling & post-market surveillance Key Requirements

  4. Medical device manufacturers • Surgical instrument producers • Dental & orthopedic equipment • Diagnostics & biotech companies Industry Use

  5. Compliance with global regulations • Improved product reliability • Higher patient safety • Access to EU & international markets • Strong documentation and traceability Benefits

  6. Specialized medical device expertise • End-to-end QMS implementation • Complete audit support • Regulatory compliance guidance Why Choose GetISOCertificate

  7. Thank You! Email Contact No Visit Our Website info@getisocertificate.com +91 95400 50215 www.getisocertificate.com

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