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 devices. Many of our employees are PhDs, with skills and experience in areas such as polymer & surface chemistry, biomaterials science and biocompatibility, as well as expertise in all aspects of heparin. We also have expertise in quality assurance, regulatory affairs, manufacturing, intellectual property and project management.
Carmeda's collaboration strengths:
- Carmeda has extensive experience in bringing their coating technologies on new medical devices through regulatory approval and on to the market.
- Carmeda is a streamlined, project-driven organization, which ensures a smooth process for feasibility studies, product development and manufacturing.
- Carmeda offers a full package of efficient design control, manufacturing, quality assurance, and regulatory support.
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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Quality Assurance
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...
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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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