Our Auditing Services Include
Comprehensive QMS Audits
We conduct detailed internal audits of your QMS to verify compliance with important standards such as ISO 13485. Our team is also experienced with related standards like ISO 9001 (general quality management), ISO 14001 (environmental management), ISO 27001 (information security), ISO 15189 (medical laboratories), and IEC 62304 (medical device software). We even consider FDA requirements like the QSR or MDSAP when relevant. Our audits evaluate all aspects of your QMS, including document control, risk management, product realization, and post-market 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 examining device descriptions, specifications, risk assessments, clinical evaluations, and post-market surveillance documentation.
Gap Analysis
We identify gaps in your QMS or technical files relative to regulatory requirements and provide recommendations for improvement. This proactive approach addresses potential issues before they escalate.
Corrective Action Plans
After each audit, we help develop and implement corrective action plans to remedy any non-conformities or improvement areas identified.
Continuous Improvement
Our audits are not just about compliance; they are a tool for continuous improvement. We focus on enhancing the effectiveness of your QMS and technical file management processes over time.
Employee Training and Engagement
We involve staff at all levels in the audit process. By training and engaging your team, we ensure a comprehensive understanding of QMS and technical file requirements, strengthening overall compliance.
Regular Updates and Follow-ups
Post-audit, we provide regular updates and follow-up support to ensure all corrective actions are implemented effectively. This helps keep your QMS and technical documentation compliant with evolving regulations.
Why Choose MDS Denmark for QMS Auditing?
Expertise
Our auditors have extensive experience with medical device regulations and quality management systems, bringing deep insight to every audit.
Tailored Approach
We customize our auditing services to meet the specific needs and complexities of your organization
Regulatory Insight
With a strong understanding of EU MDR and IVDR, we ensure that your QMS and technical files are not only compliant but also aligned with industry best practices.
ENSURING EXCELLENCE AND COMPLIANCE
MDS Denmark is dedicated to helping your organization maintain the highest standards of quality and regulatory compliance. Our auditing services for QMS and technical files are a critical step toward achieving excellence in medical device manufacturing and ensuring patient safety.