ISO 13485 Audits
ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for medical devices. It outlines the criteria for organisations involved in the design, development, production, installation and servicing of medical devices to ensure compliance with regulatory requirements and consistently meet customer expectations.
Our team can provide ongoing expertise and guidance to ensure your ISO 13485 audit process remains thorough, compliant and effective, by offering insights into best practices, regulatory requirements, and opportunities for improvement across your medical device QMS.
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Featured case studies
Prosthesis manufacturer
Prosthesis manufacturer Introduction As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months. Types MDSAP Audit Preparation, Quality Management System Review Scope of work Selecting the certification body (quotes, Q&A) Review of their quality management system…
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification. Standards & Tools 21 CFR ISO 13485 MDSAP MDR Scope of work Key numbers Excited to work together…