In the medical device industry, reliability and regulatory compliance count. With over 30 years of industry experience, meocra offers you ISO 7 cleanroom production on an area of almost 280m² that meets both ISO 13485 and MDR requirements. Our goal: to manufacture your plastic-based medical device products quickly, safely and in consistently high quality.
Why Mecora is the right partner for cleanroom production
Efficient processes and short project durations:
We ensure close coordination between engineering and production, thus accelerating your time-to-market.
Flexible quantities:
In our clean rooms, we manufacture from 50 units per year up to medium batches – and we can scale up at any time, according to your needs.
Second-Source-Option:
We are supplying additional capacity to secure your supply chain. Specialized cleanroom personnel: Trained specialists ensure smooth production and assembly of your products
Validated Processes & Certification:
Through ISO 13485 and regular audits, we score points with consistent quality standards.
Processes and procedures in
cleanroom production at mecora:
In-house mouldmaking
Thanks to our own machinery, we manufacture the moulds for your plastic components directly on site. This allows us to ensure smoothly coordinated series production and to react quickly to adjustments if necessary.
Production of plastic components
On our machines, we produce the required components using various technologies and processes. We always adapt the process to your specific requirements – for constant shape accuracy and high quality
Assembly in the cleanroom
In our ISO 7 clean rooms, the manufactured components and, if necessary, supplied components are professionally assembled. Here you benefit from our trained staff, who ensure that all processes are carried out precisely and hygienically flawlessly.
Packaging & Labeling
As a full-service provider, we take care of the standard-compliant packaging and labelling of your products. In doing so, we take into account regulatory and device specifications as well as sterility requirements so that your goods reach the users intact and compliant.
Logistics
We also take care of shipping your products – directly to your warehouse or to the end customer. This means that your medical devices reach their destination safely and quickly, while you can fully concentrate on your core business.
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 manufacturing 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.