MedTech Internal Audits

Elevate your quality management system (QMS) with Rephine’s expert internal audit services.

Our team ensures your QMS aligns with ISO 13485, MDR, and other regulatory requirements, enhancing both compliance and patient safety.

Understanding Internal Audits in MedTech

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.

Medtech Internal Audit Intro Hero Image

Challenges in MedTech Compliance & Quality

REPHINE ORANGE ACCENT FWD THINKING ICON
REPHINE ORANGE ACCENT COMMITMENT INNOVATION ICON

What are the typical challenges companies face with internal audits?

How does Rephine’s internal audit service address these challenges?

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.

Benefits of MedTech Internal Audits

REPHINE ORANGE OUTLINES COMM PARTNERSHIPS ICON

Compliance Assurance:

Internal audits validate adherence to ISO 13485, MDR/IVDR, and 21 CFR 820 requirements, essential for maintaining a compliant QMS.

REPHINE ORANGE OUTLINES QMS DEVELOPMENT ICON

Enhanced Quality:

Through detailed reviews and objective insights, internal audits help improve device quality and safety.

REPHINE ORANGE OUTLINES PRE SUBM REVIW ICON

Objective Evaluation:

 External auditors provide unbiased assessments that uncover gaps often overlooked by internal teams.

REPHINE ORANGE OUTLINES POST SUBM LIFECYCLE ICON

Continuous Improvement:

 Internal audits form a cornerstone for continuous improvement, identifying areas for CAPA and long-term quality enhancement.

two scientist professional uniform working laboratory LR

Rephine's MedTech Internal Audit Service

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:

  • Comprehensive evaluation aligned with ISO 13485, MDR/IVDR, and other standards
  • Clear process from planning to CAPA follow-up
  • Independent auditors with deep knowledge in medical device regulations
  • Detailed reports and recommendations for QMS improvement

Rephine’s Audit Approach

Rephine’s internal audit process is comprehensive and structured to cover each phase thoroughly, with an emphasis on transparency and collaboration:

Ready to Enhance Your QMS with Rephine’s Internal Audit Expertise?

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.

Common Questions About MedTech Audits

Why choose an external partner like Rephine for internal audits?

Rephine’s auditors bring external objectivity and deep regulatory expertise, enhancing your internal audit process by providing unbiased insights. Our independence helps us identify non-conformities that internal teams might overlook, adding value by offering a fresh perspective on your QMS.

What can companies expect from a Rephine internal audit?

Rephine’s internal audits involve an end-to-end review, starting with scope definition and an audit plan. During the audit, we evaluate processes, document control, training records, and more to ensure compliance. Afterward, we provide a detailed report with clear recommendations and offer CAPA support for effective remediation.

How does Rephine support post-audit improvement?

After the audit, we offer CAPA planning to address findings. Our team collaborates closely with your internal stakeholders to develop CAPAs that effectively close gaps and embed best practices for continuous improvement.

Advantages of partnering with Rephine

REPHINE MD ORG STAFF CUSTOMERS ICON

Deep Regulatory Expertise:

Our auditors stay updated with the latest in ISO 13485, MDR/IVDR, and other regulatory changes, ensuring your audit is relevant and thorough.

 

Objective and Transparent Reviews:

Rephine’s external perspective brings a level of objectivity that internal teams may struggle to achieve.

REPHINE MD ORG DOCS APPROVAL ICON

Comprehensive CAPA Support:

Our team not only identifies issues but also collaborates with you to develop CAPAs for lasting quality improvements.

REPHINE MD ORG SERVICE OFFERING ICON

Scalable, Flexible Service:

From start-ups to large enterprises, Rephine customises audits to fit your specific needs, ensuring efficient and effective results.

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

Global Audit Library

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

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

Contact Us