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We specialize in assisting medical device manufacturers, wholesalers and distributors in achieving compliance with ISO 13485 standard, which pertains to quality management systems (QMS) for the medical device industry. Achieving ISO 13485 certification for your medical device company demonstrates a commitment to quality and patient safety. But navigating the intricacies of the standard and building a compliant Quality Management System (QMS) can be daunting. We are here to assist you through the following services:

1. QMS Development

    • Gap Analysis: We assess your current practices against the ISO 13485 requirements, identifying gaps and areas needing improvement.
    • Documentation Development: We create or refine your QMS documentation, including policies, procedures, work instructions, and records.
    • Training: We provide comprehensive training for your staff on ISO 13485 requirements and your QMS procedures.

1. QMS Implementation and Maintenance

  • Process Implementation: We guide you in implementing the documented QMS processes within your organization.
  • Change Management: We assist with managing changes to your QMS, ensuring continued compliance with the standard.
  • Internal Audits: We conduct regular internal audits to assess the effectiveness of your QMS and identify areas for improvement.

3. QMS Internal Audit

  • Audit Planning and Scoping: We work with you to define the scope and objectives of your internal audits.
  • Audit Execution: We conduct thorough audits of your QMS, following established audit methodologies and document audit findings, and prepare audit reports.