Quality

Quality is the backbone of medical device development and manufacturing

Formal ISO 13485 design and development process is used consisting of 8 phases:  Requirements, Risk Analysis, Detail Design, Verification, Engineering Release, Clinical/Regulatory, Design Transfer, and Sustaining support.

ISO 13485 compliant manufacturing including purchasing, receiving, receiving inspection, lot traceability, kitting, work instructions, in process testing, CNC machining, polymer component production, box build, packaging and shipping. 

Environmental controls include ESD protection, relative humidity, ISO cleanroom particulate and microbial, sterile air supply, ultrapure nitrogen supply, RO water, ionizing air gun (inside and outside cleanroom), incubators and temperature chambers.