Since 1993, mecora has been manufacturing sterile packaged disposables for the medical device industry and has been certified for this since 1996. Thanks to our quality management in accordance with DIN EN ISO 13485 and our international experience, we support you in all quality-relevant processes – from development to production. We attach particular importance to smooth processes in the documentation, testing and approval of your products.
This allows you to concentrate on your core competencies.
Mecora is your partner in quality assurance
Complete process support:
We accompany your product from the idea to series production, which ensures quality throughout.
Efficient documentation:
mecora works with well thought-out structures and digital systems so that we keep bureaucratic effort low and ensure traceability.
Continuous improvement:
Regular audits and training ensure that our quality processes are always up to date - for even better results for every project.
Long-standing certification:
Since 1996, we have consistently met the requirements for sterile packaged medical devices.
Certification & Validation
ISO 13485:
Guarantor of a comprehensive quality management system that covers all regulatory requirements of the medical technology industry.
MDR Compliance:
We consistently align our processes with the EU regulations (Medical Device Regulation).
Regular audits & trainings:
Both internally and externally, we are continuously reviewing our processes to meet current requirements.
Documentation & Traceability:
Complete traceability ensures maximum security and simplifies collaboration. Draw on our many years of expertise.
Your advantages with mecora as your cleanroom production partner
Quality
Validated processes and certified quality management.
Scalability
Quantities as required, without compromising on reliability.
Time saving
Fast implementation thanks to efficient processes and short decision-making paths.
Supply chain security
Supply chain security: second-source option to cushion production bottlenecks.