Carmeda has built quality into the technology by integrating quality assurance into all activities, from research and product development to manufacturing, training, and documentation.
Carmeda's quality management system meets the requirements of both FDA Quality System Regulation 21 CFR Part 820 and ISO 13485. Carmeda is audited by a Dutch notified body for medical devices, DEKRA. Regular supplier audits are also performed by customers.
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Our People
Carmeda has a staff of dedicated people in a range of fields, such as Research & Development, Quality Assurance, and Manufacturing.
Our organization has more than 35 years of experience developing and manufacturing biocompatible coatings for medical...
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Manufacturing
The CARMEDA® BioActive Surface is applied to a range of medical devices in our clean room.
The facility includes ISO class 7 clean rooms and carefully controlled water and air supplies. This enables coating...
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Regulatory Affairs
The Regulatory Affairs team is an important part of Carmeda’s organizational structure.
Our professionals are actively involved in providing documentation of our technology and regulatory expertise for...
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Research & Development
The R&D department offers a comprehensive range of skills and various methodologies to support all aspects of surface characterization and coating development.
Many of our R D employees are PhDs, with skills and experience in areas such as polymer surface chemistry, biomaterials...
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