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Achieving ISO 13485 certification is crucial for maintaining high standards in the medical device industry. Our ISO 13485:2016 Documentation Toolkit is designed to help you meet these standards efficiently. The toolkit includes a comprehensive quality manual, a range of procedures, SOPs, process flow charts, and an audit checklist with over 900 questions, all tailored to ISO 13485 requirements. These documents are easy to use and understand, developed under the guidance of experienced ISO consultants. To further support your certification journey, we offer consultancy services that provide personalized document preparation and ongoing assistance through digital platforms, ensuring a smooth and cost-effective implementation and audit process.

Source link: https://www.documentationconsultancy.com/iso-13485-documents.html

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