ISO 13485
ISO 13485 Quality Management System
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Medical device manufacturing is one of the most regulated sectors in which significant quality systems
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The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS.
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Here & Now auditors are experts in current state-of-the-art and are constantly trained on new requirements
and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.
Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.
and future changes. Here & Now is always looking ahead to ensure that our clients are prepared and well placed for future changes to compliance and the regulatory landscape. The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system.