Internal Auditing for Quality Management Systems and Technical Files

At MDS Finland, our approach to internal auditing for Quality Management Systems (QMS) and Technical Files is designed to ensure the highest level of compliance and efficiency. We understand that internal auditing is a critical component in maintaining the integrity and effectiveness of QMS and Technical Files, especially under stringent regulatory frameworks like the EU MDR and IVDR.

Our Internal Auditing Services

Comprehensive QMS Audits

We conduct detailed internal audits of your QMS to ensure compliance with international standards such as ISO 13485. Our audits evaluate all aspects of the QMS, including document control, risk management, product realization, and postmarket activities.

Technical File Review

Our experts meticulously review your technical files to ensure they meet the requirements of the EU MDR and IVDR. This includes a thorough examination of device descriptions, specifications, risk assessments, clinical evaluations, and post-market surveillance documentation.

Gap Analysis

We identify any gaps in your QMS and technical files against regulatory requirements and provide recommendations for improvement. This proactive approach helps in addressing potential issues before they escalate.

Corrective Action Plans

Following the audit, we assist in developing and implementing corrective action plans to address any non-conformities or areas of improvement identified during the audit.

Continuous Improvement

Our internal audits are not just a compliance exercise; they are a tool for continuous improvement. We focus on enhancing the effectiveness of your QMS and technical file management processes.

Employee Training and Engagement

We believe that a successful audit process involves staff at all levels. Our approach includes training and engaging your team to ensure a comprehensive understanding of QMS and technical file requirements.

Regular Updates and Follow-ups

Post-audit, we provide regular updates and follow-up to ensure that all corrective actions are implemented effectively and that your QMS and technical files remain compliant with evolving regulations.

Why Choose MDS Finland for Internal Auditing?


Our team of auditors brings extensive experience in medical device regulations and quality management systems.

Tailored Approach

We tailor our auditing services to meet the specific needs and complexities of your organization.

Regulatory Compliance

With a deep understanding of the EU MDR and IVDR, we ensure that your QMS and technical files are not just compliant but are also aligned with best practices.

Ensuring Excellence and Compliance

MDS Finland is dedicated to supporting your organization in maintaining the highest standards of quality and regulatory compliance. Our internal auditing services for QMS and technical files are a critical step towards achieving excellence in medical device manufacturing and ensuring patient safety.