For medical device companies, internal audits are essential to maintaining compliance, ensuring patient safety, and achieving continuous improvement.
Annual internal audits not only identify gaps in a QMS but also promote proactive improvements and help avoid costly compliance issues.
Rephine’s internal audit services provide manufacturers, importers, and distributors with a comprehensive evaluation aligned with the latest standards like ISO 13485, MDR, and 21 CFR 820.
Medical device companies often lack the resources or internal expertise to conduct thorough internal audits. Common challenges include an incomplete review of processes, insufficient knowledge of evolving regulations, and limited implementation of effective corrective actions.
 Rephine provides solutions through our expert auditors who deliver a comprehensive, unbiased assessment of your QMS.
Rephine’s auditors bring extensive industry knowledge, offering independent insights that go beyond internal perspectives.
Our process covers all essential QMS elements, from planning through execution and CAPA support, ensuring that our clients meet regulatory expectations.
Internal audits validate adherence to ISO 13485, MDR/IVDR, and 21 CFR 820 requirements, essential for maintaining a compliant QMS.
Through detailed reviews and objective insights, internal audits help improve device quality and safety.
 External auditors provide unbiased assessments that uncover gaps often overlooked by internal teams.
 Internal audits form a cornerstone for continuous improvement, identifying areas for CAPA and long-term quality enhancement.
Our MedTech internal audit service is tailored to provide a thorough, independent assessment of your QMS. With Rephine’s audit process, medical device companies receive a structured evaluation focusing on compliance, risk mitigation, and quality enhancement. Our auditors use a risk-based approach to ensure all essential areas are thoroughly reviewed, particularly those with the greatest impact on compliance and patient safety.
Service Features:
Rephine’s internal audit process is comprehensive and structured to cover each phase thoroughly, with an emphasis on transparency and collaboration:
Connect with our team today to discuss your needs and schedule an internal audit tailored to your company.
Book a free 30-minute discovery call to gain insights into how we can support your compliance and quality objectives.
Our auditors stay updated with the latest in ISO 13485, MDR/IVDR, and other regulatory changes, ensuring your audit is relevant and thorough.
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Rephine's external perspective brings a level of objectivity that internal teams may struggle to achieve.
Our team not only identifies issues but also collaborates with you to develop CAPAs for lasting quality improvements.
From start-ups to large enterprises, Rephine customises audits to fit your specific needs, ensuring efficient and effective results.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
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