We are proud of the strong product development process that we follow. The process is based on Design Excellence methodology i.e. DMADV2 of product development. We are ISO 9001 and ISO 13485 certified organization. We have set our processes in line with ISO 13485, MDD 93/42/EEC, and US FDA requirements.
The device under development is refined over a period of time with reviews carried out by independent reviewers, at each stage of product development. We lay a strong emphasis on worthiness and transparency of verification and validation data. We also follow ISO 14971, ISO 10993 and other product specific ISO standards during product development. We also follow ISO 11135 for sterilization process.