Deslyon helps guide organisations through the ISO 13485 certification process. Our expert team assesses your current QMS, identifies gaps, and recommends improvements to ensure compliance. We provide tailored training and ongoing support, enabling your organisation to confidently achieve ISO 13485 certification, showcasing your dedication to safe and effective medical devices, and building trust with customers and regulators.
ISO 13485 is an internationally recognised standard for designing, manufacturing and distributing medical devices. It outlines the requirements for a comprehensive Quality Management System (QMS) tailored explicitly to medical device manufacturers and related service providers. The standard ensures that these organisations consistently meet customer expectations and regulatory requirements while maintaining the safety and effectiveness of their products.
Organisations that should implement ISO 13485 include medical device manufacturers, component manufacturers, contract manufacturers, service providers, and distributors. These companies benefit from implementing the standard as it ensures consistent quality and regulatory compliance and demonstrates their commitment to safety throughout the product lifecycle.
Additionally, regulatory bodies and certification organisations can adopt ISO 13485 to promote and enforce quality standards in the medical device industry. Organisations designing, manufacturing, distributing, or servicing medical devices or related components should consider implementing ISO 13485 to ensure quality, safety, and regulatory compliance.
Implementing ISO 13485 brings a multitude of benefits to organizations in the medical device industry, improving overall efficiency, quality, and customer satisfaction.
Key benefits of ISO 13485 Certification:
There are several misconceptions about ISO 13485, which can lead to confusion and misunderstandings.
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