As an experienced Contract Development Manufacturer Organisation for over 30 years…
Partnering with a CDMO gives you access to specialised expertise, state-of-the-art technology, and a streamlined manufacturing process. Together, we are dedicated to pushing the boundaries of innovation, ensuring the highest quality standards, and ultimately, improving patient outcomes. Our ability and resources can cater to customer’s desired production quantity. We have the necessary space and equipment to increase production, yet also have the ability to downsize when needed. We are able to fully support your innovation journey from its seed concept, all the way till prototyping and mass manufacturing.
Explore our website to learn more about how this strategic alliance is shaping the future of healthcare.
CDMOs assist MedTech companies in the development of new medical devices. This can include services such as product development, process development, analytical method development, testing and clinical trial support.
Equipped with manufacturing capabilities to produce low or high-mix medical products on a contract basis. This includes the production of plastic molded parts, non-plastic components, PCBA, and even reagent. Racer have state-of-the-art facilities that can comply with regulatory standards, such as FDA and ISO 13485 QMS Standards.
Our commitment to you is upheld through our dedicated processes
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- Engineering & Assay Development
- Human Factor Engineering
- Class II / III Precision Medical Devices
- Design Thinking
- Low Cost Prototype Tool
- Concept to DFM
- Process Development and Engineering
- Strategic Components & Procurement
- Functional and Performance Testing
- Product Certification
- Risk Management
- Product Regulatory
- ISO 13485 / 9001 / 14004 Compliant
- FDA and EU Regulation, Reliability, and Usability Testing
- IOPQ Validation
- ISO 10K and 100K Cleanroom Manufacturing
- Precision Tooling
- Contract Manufacturing
- Factory 4.0 Process and Manufacturing
- Aliquoting and Sterilisation
- Full-Turnkey Assembly / Sub-Assembly
- Primary and Secondary Packaging
- Sterile and Non-sterile Packaging
- Regulatory Labelling
- Regional Fulfilment and Logistics