Clinical Operations-Design to Execution

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Showing posts from October 4, 2009

QA & Regulatory Compliances etc.: ISO Management Standards for Medical Devices

QA & Regulatory Compliances etc.: ISO Management Standards for Medical Devices BayBiotech.NET www.baybiotech.net

ISO Management Standards for Medical Devices

Two main ISO standards that have a direct application to Medical Device Industry are ISO 9001 and ISO 13485. While ISO 9001 is for evolving a Quality Management System for an organization, ISO 13485 has a direct application to Medical Device Industry. Although, ISO standards for a company are not a legal requirement, but provide a validation and ease of global marketing of the product.