Product quality and performance, delivery precision, and patient safety are of the utmost important to us. We always strive for the highest quality with the greatest flexibility, using validated production processes to systematically eliminate defects, deficiencies, and significant variances.
A well planned and performed process validation is an important work to ensure that you have a well-controlled manufacturing process consistently producing conforming products. Non-conforming products could lead to human injury or result in costly product recalls. By implementing a successful validation process, medical device manufacturers can improve productivity, reduce recalls and consumer complaints and also reduce the burdensome process of investigations.
Regulations and ISO standards applicable for medical devices require that validation of a manufacturing process shall be performed. In fact, both the U.S. Quality System Regulation 21 CFR Part 820 and ISO 13485:2016 have explicit elements requiring the manufacturer to perform tasks associated with validation, such as installation qualification (IQ), operational qualification (OQ) and performance qualification.
Elos Medtech holds skilled and experienced people following well established processes and procedures for how process validations shall be planned, executed and documented accordingly.