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ISO 13485 and QMS Support

Medical Devices & IVD

Why ISO 13485 is Mandatory?

ISO 13485 is the widely used international standard for quality management in the medical device industry, issued by the International Organization for Standardization (ISO), providing a comprehensive solution for a Quality Management System. 

It focuses on patient safety and quality. It demonstrates compliance with various global regulatory requirements, making it easier to obtain approval for medical devices. ISO 13485 ensures consistent quality and safety of medical devices throughout their lifecycle, from design to disposal. 

Implementing this standard helps organizations establish a robust quality management system, minimizing errors and prioritizing patient safety. It also provides market access by demonstrating commitment to quality and patient safety, opening doors to new markets that may require stringent quality standards. ISO 13485 is globally recognized, accepted by regulatory bodies and healthcare institutions worldwide.

ISO 13485 Requirements

Clause 4-8 outlines the ISO 13485:2016 requirements that your organization must meet to achieve ISO 13485 certification. The Clause 4 outline the Quality Management System (QMS) documentation requirements, including a Quality Manual, Procedures, Forms & Records, and Document Control. The Clause 5 outlines the management’s role within the QMS, including Quality Policy, Objectives, Customer Focus, and Management Review. 

Clause 6 involves setting requirements for personnel and training. Clause 7 involves defining requirements for production, planning, customer-related processes, design, purchasing, process control, identification and traceability, and customer property. The Clause 8 outlines steps for monitoring and enhancing processes, including customer satisfaction, internal audits, control of non-conforming products, and corrective and preventive action.

The advantages of acquiring ISO 13485 certification include

  • Enhancing the quality and transparency of your processes.
  • Securing the quality, safety, and performance of your medical devices.
  • Elevating brand reputation and fostering consumer trust and satisfaction.
  • Preventing costly product recalls through the consistent delivery of quality and safety.

Supplier Audits

Internal Audits

Lead Auditor Support

Process and Procedure Validation

Document Compiling and Writing

Gap Analysis

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