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Medical Equipment on Desk

Quality Assurance Services

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  • Compliance Audits and Inspections: Conducting internal audits and preparing for regulatory inspections to ensure compliance with regulatory standards. 

  • Quality Management Systems (QMS): Assisting in the development, implementation, and maintenance of quality management systems in compliance with regulatory standards such as ISO 13485, GMP, and GLP. 

  • Post-Market Surveillance: Assisting with post-market activities such as adverse event reporting, periodic safety update reports (PSURs), and product recalls. 

  • Training and Education: Offering training programs to keep clients' staff updated on regulatory requirements and best practices.

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