Expertise.
ISO 13485 certification.
Implement a robust ISO 13485 QM system for sustainable compliance and product safety.
Reliable?
Does your QM system meet the high quality standards of the medical technology industry?
Compliant?
Are your processes fully ISO 13485-compliant and auditable?
Efficient?
Are you optimizing your production processes to increase efficiency and minimize errors?
Do you need support in implementing an ISO 13485 QM system?
Implementation of an ISO 13485-compliant QM system.
We support you in the development and implementation of an ISO 13485 QM system that is specifically tailored to the requirements of the medical technology sector.
ISO 13485 certification is the internationally recognized standard for quality management systems in medical technology. Our experts analyze your existing processes and implement a robust quality management system that meets all regulatory requirements and prepares your products for market access.
Our services include:
- Requirements analysis: Review of existing processes and identification of gaps in ISO 13485 conformity.
- Creation of documentation: Creation and management of the necessary documentation to prepare for ISO 13485 certification.
- Education and training: Conducting training to ensure that all employees understand and implement the ISO 13485 requirements.
ISO 13485 QM systems - your quality management put to the test.
Our ISO 13485 Consulting Services offer comprehensive support in the implementation and optimization of a compliant quality management system.
ISO 13485 implementation.
- Analysis of existing processes and identification of optimization opportunities
- Implementation of an ISO 13485-compliant QM system
- Development of customized solutions for your company
Documentation and audit preparation.
- Creation and maintenance of ISO 13485 documentation
- Preparation for internal and external certification audits
- Implementation of a documentation system for auditability
Proactive risk management.
- Introduction of a risk management system in accordance with ISO 13485
- Preventive measures for quality control and product safety
- Support in the continuous monitoring and improvement of your processes
Successful projects for ISO 13485 certification.
Our ISO 13485 case studies show how companies have successfully achieved ISO 13485 certification through optimized processes and a strong quality management system.
ISO 13485 implementation at a medical technology company
Optimization of process automation for ISO 13485 at a medical technology company
Risk management strategies for ISO 13485 compliance at a start-up
Challenge.
A medical technology start-up needed support in implementing a risk management system in order to establish ISO 13485-compliant processes.
Measures.
- Carrying out a comprehensive risk assessment along the entire production chain
- Development of a customized risk management system for the preventive detection of quality problems
- Implementation of real-time data analyses for early detection of deviations and potential risks
Results.
- Reduction of the risk of quality problems by 30%
- Increased product safety and quality through continuous monitoring
- Compliance with ISO 13485 standards, giving the company market access for new products
Success.
The start-up was able to obtain ISO 13485 certification and successfully place its products on the market.
Optimize your quality management system in accordance with ISO 13485.
Our ISO 13485 QM service portfolio.
Our ISO 13485 QM service portfolio offers comprehensive solutions for the development and optimization of an ISO 13485-compliant quality management system.
We ensure full compliance of your processes with the ISO 13485 specifications. Our experts create technical documentation, carry out internal audits and provide support in preparing for external certification audits.
- Gap analysis and documentation: : We identify potential gaps in your existing QMS and help with the complete creation and maintenance of technical documentation
- Audit preparation: Support in preparing for certification audits and ensuring that all regulatory requirements are met
Our digital solutions help you to increase the efficiency of your quality management processes and improve traceability.
- Digital QM solutions: We integrate real-time data monitoring and automated QM tools to improve traceability and reduce manual processes
- Process control: Optimization of processes to ensure compliance, data integrity and efficient monitoring of production processes
We implement a preventive risk management system that ensures that potential risks in production are identified and minimized at an early stage.
- Risk analysis: Implementation of a comprehensive risk management system in accordance with ISO 14971 to identify and assess risks
- Quality monitoring: Ongoing monitoring and evaluation of processes to ensure product quality and eliminate risks at an early stage
