Medical Devices and IVDs

ISO 13485 and QMS Support

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

1. We conduct pre-qualification audits to assess a supplier's ability to meet quality requirements before awarding contracts.

2. We perform ongoing supplier audits to ensure continued compliance with specifications and regulatory standards.

3. Our audits cover all aspects of the supplier's QMS, including quality control, documentation, and recordkeeping.

Internal Audits

1. We conduct internal audits to evaluate the effectiveness of the existing QMS and identify areas for improvement.

2. Our audits are tailored to specific needs and risks, ensuring they address critical processes and procedures.

3. We provide comprehensive audit reports with findings, recommendations, and corrective action plans.

Lead Auditor Support

1. We train and mentor internal staff to become qualified lead auditors, enabling independent internal audits.

2. We offer on-site support during internal audits, providing guidance and expertise.

3. This increases audit efficiency and builds internal team capabilities.

Process and Procedure Validation

1. We validate critical processes and procedures to ensure they consistently meet quality requirements.

2. We use recognized validation methodologies and provide documented evidence.

3. This helps demonstrate regulatory compliance and ensures process reliability.

Document Compiling and Writing

1. We assist in compiling and writing documentation for ISO 13485 and ISO 9001 certifications.

2. Our team has extensive experience in medical device regulations and standards.

3. We offer support to maintain and update documentation as the QMS evolves.

Gap Analysis

1. We conduct gap analyses to assess compliance of the existing quality system with relevant standards.

2. We identify areas requiring improvement to achieve certification or maintain compliance.

3. This helps prioritize corrective actions and create a clear improvement roadmap.

Beyond These Specific Services, We Also Offer

1. Expert advice and guidance on regulatory compliance and best practices.

2. Ongoing support to maintain and improve the QMS over time.

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