Process + Capabilities
The experienced Indilab team will provide strategic guidance and support at every stage of the product development process.
Indilab is a FDA regulated company that carries ISO 13485:2016 certification. We can ensure that your products will be managed with strict adherence to all applicable Standard Operating Procedures and Manufacturing Processes. We offer confidentiality agreements for all proprietary formulations.
Throughout the development process all activities are designed and documented to meet the stringent requirements set forth by the FDA, as well as international standards. Our global regulatory expertise reduces non-conformance and ensures that finished products are safe and effective.
Our experienced design team will assist you with:
- Outsourcing, private-labeling or developing new process indicators or indicator applications for steam, ethylene oxide and hydrogen peroxide plasma sterilization systems.
- Design and development of new products or provide turnkey operations throughout the entire design control life cycle including
- Design input
- Validation and verification activities
- Market clearance
- Post market surveillance
- Specialized guidance
- Tactical support
- Manufacture chemical sterilization indicator products and indicator applications for steam, ethylene oxide and hydrogen peroxide plasma sterilization systems for:
- Medical Devices
- Dental Devices
- Healthcare Products Distributors
- Develop Proprietary Branded Products and Indilab Branded Products
- Deliver value added products and services
- Assist in the development of new technologies for healthcare manufacturers
- Implement smart and responsive business practices
- Develop and maintain cost-effective, long-term sterilization solutions