Audits in the medical device industry – Preparation, implementation and optimization
Audits are the key for reviewing and continuously improving the quality, compliance and efficiency of your processes. Whether internal or supplier audits – I support you in mastering the challenges and making your organization fit for all applicable requirements.
My audit services
Internal audits: Planning, execution and documentation of internal audits according to ISO 13485 and other relevant standards to review and optimize your processes and systems.
Supplier audits: Evaluation and monitoring of your suppliers to ensure quality and compliance throughout the supply chain.
Audit preparation: Helping you prepare for external audits, including certification audits and regulatory inspections.
Audit documentation: Provide detailed reports with clear and unambiguous resultsProvide detailed reports with clear and unambiguous results.
Corrective Action (CAPA): Development and implementation of actions to correct identified nonconformities.
Audit Training: Training your team to pass audits safely and successfully – practical and effective.
Ongoing support: Long-term support in the implementation of improvement measures and monitoring progress.
The Benefits of Professionally Performed Audits
Ensure compliance: Audits ensure that your processes meet regulatory and standard requirements.
Improve quality: Identify weaknesses and take corrective action.
Trust and transparency: Professional audits strengthen the confidence of customers, partners and authorities in your company.
Risk minimization: Early detection of problems
Efficiency and Sustainability: Optimized processes save time and resources – without compromising quality.
With my experience in the medical device industry and extensive expertise, I ensure that your audits are not just a test, but an opportunity for further development and optimization. Together, we can take your processes and supply chains to the next level.
Let’s work together to make your audits efficient, secure and future-ready.