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:

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.

Documentation and audit preparation.

Proactive risk management.

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.

Challenge.

A medical technology company had to introduce a comprehensive QM system in accordance with ISO 13485 in order to guarantee the quality of its products.

Measures.

  • Carrying out a comprehensive process analysis to identify optimization potential
  • Implementation of a customized ISO 13485 quality management system
  • Training the team to ensure compliance with ISO 13485 requirements

Results.

  • Successful ISO 13485 certification
  • Optimized processes and increased product safety
  • Reduction of the error rate in production by 25%

Success.

The company 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

Achieve ISO 13485 certification for your medical device.

Related topics for the quality assurance of your medical devices.

These supplementary services support you in implementing and optimizing your quality management system in accordance with ISO 13485:
CAPA Management
Optimize your processes with a robust CAPA system to ensure compliance and ...
Inspection Readiness
Ensure that your products and processes comply with regulatory requirements.
Risk Management
Identify and minimize risks with solutions for the pharmaceutical and medical technology industries.
Annex 1
Ensure that your processes meet the new Annex 1 requirements for sterile products ...