Expertise.
Complaint Management.
Effective complaint management for the life sciences industry.
Efficient?
Is your complaint management efficient enough to process all complaints on time?
Compliant?
Do your processes meet the regulatory requirements for complaints management?
Structured?
Are your processes clearly structured to implement CAPA measures effectively?
Improve your complaint management.
Efficient Complaint Management for Life Science.
Our Complaint Management Service helps you to process complaints efficiently and in a structured manner while at the same time meeting regulatory requirements.
Complaints must not only be processed quickly, but also documented and tracked in accordance with regulatory requirements. Our Complaint Management supports you in optimizing your processes and ensuring that complaints are handled efficiently. We place particular emphasis on the implementation of CAPA measures in order to resolve systematic problems in the long term.
Our services include:
- Regulatory strategy: Development of a customized strategy to meet the regulatory requirements of your products and accelerate market access.
- Submission and communication: Support with the preparation and submission of all necessary documents and communication with the relevant authorities.
- Compliance management: Implementation of a robust compliance management system to ensure continuous compliance with all regulatory requirements.
Our services at a glance.
Our complaint management covers all relevant aspects of complaint processing, from documentation to the implementation of corrective measures.
Complaint processing.
- Structured recording and processing of complaints
- Creation of reports for internal and external purposes
- Timely follow-up and resolution of customer complaints
Regulatory reporting.
- Preparation of reports in accordance with MDR/IVDR and other standards
- Regular review and updating of processes
- Preparation for official audits and inspections
CAPA management.
- Implementation of preventive and corrective measures (CAPA)
- Analysis of causes of complaints and systematic problems
- Monitoring CAPA measures to ensure sustainability
Case studies: Successful Complaint Management.
Our projects help companies to optimize their complaints processes and meet regulatory requirements.
Optimization of complaint management for a medical technology company
CAPA implementation in the life science industry
Efficient reporting and audit preparation for a medical technology company
Challenge.
A medical technology company had to prepare for an upcoming official inspection that focused on complaint management.Measures.
- Revision and optimization of complaint management processes
- Creation of a compliant reporting system in accordance with the MDR
- Carrying out an internal mock inspection in preparation for the official audit
Results.
- Successful official inspection without objections
- Improved documentation and traceability
- Strengthening the internal complaint management system
Success.
The company successfully passed the official inspection and was able to sustainably improve its processes.Optimize your complaint management.
Our service portfolio.
Our Complaint Management portfolio covers all aspects of complaint processing and CAPA management.
Our specialized teams support you in the structured recording and processing of customer complaints. From the initial notification to the final resolution, we ensure that every complaint is processed and documented in a timely manner. Our structured approach improves traceability and helps you to strengthen customer relationships.
Meet all regulatory requirements with our comprehensive reporting support. We prepare reports in accordance with applicable regulations such as MDR and FDA and ensure that all processes are transparent and auditable. Our experts will also prepare you for audits to ensure a successful regulatory inspection.
An effective CAPA system is the key to long-term quality assurance. We analyze the causes of complaints, identify systematic problems and implement preventive and corrective measures. Our monitoring systems ensure that CAPA measures have a lasting effect and that recurring problems are minimized.
Optimize your complaint management and ensure regulatory compliance.
Solutions for effective complaint management.
Optimize your complaint management with our specialized services and ensure that you systematically use customer feedback to improve the quality of your products:
