MedTech
The integrated solution for MedTech
You provide medical devices of the highest quality and state-of-the-art technology to your customers, and you want to anticipate the adaptability of your ERP with the European Medicines Agency (EMA) Master Data Management Roadmap strategies
Active in the national and international markets, you are subject to regulations such as GMP, FDA 21 CFR part 11, 210, 211, 820, ISO 13485. Therefore, data integrity is of utmost importance for your company.
The processes based on GAMP are an integral part of governance in your organization, and you must be able to completely track all your manufacturing processes in terms of operators, machines and materials.
Certifications and audits of your suppliers, certification for your products, and simultaneous management of several product versions, you need a partner who has the relevance experience to understand your requirements !
"In collaboration with ProConcept, we use a custom ERP system that allows us to meet the demanding production standards of the pharmaceutical industry."
Your business specifics and requirements
| Complete traceability, recall | Quality flow and statuses | Storage conditions | Expiry and reanalysis |
| Versioning / Version management (Master Batch Record) | Double signature | Audit trail | Partner evaluations and audit |
| Non-conformities | Certifications / branding | Sampling | Quality norms |
ProConcept for Medical Devices: regulatory compliance at a competitive price
As a result of its numerous collaborations and co-developments with its customers all over the world in the field of pharmaceuticals and medical devices, ProConcept for Medical devices combines its power in the field of complex manufacturing with a large number of standard features specific to the enterprises subject to regulations, such as a simple-double electronic signature, test and retest, robust audit trail compliant with 21 CFR part 11, easy management of product versions, complete traceability, etc.
The flexibility of configuration and its agility make ProConcept completely adaptable to your processes and your manner of working.
Our MedTech references
ProConcept is a tried and tested solution for companies in the scientific instrumentation and medical technology sectors. The aim of an ERP system is to control a complex manufacturing environment, and adhere to strict quality and standardization conditions in your industry sector.
