The equipment reliability and its safety are the most important features of any product for the medical market. It requires a strict development, in line with necessary regulations, using defined design methods, with proper risk management and certifications.
ICU tech will deliver your product, that conforms to the standards, to the market, on time.
- development according to the norm for medical products ISO 13485, MDD 93/42
- software design and development accordingly to IEC 62304
- hardware development accordingly to IEC 60601-1
- execution of risk analysis in line with ISO14971 (FMEA, FTA)
- support for the product registration
ICU tech, with its experience in hardware and software development and ISO 13485 certification, is the perfect partner for you.