Glenview IL – July 10, 2019 - LCR Hallcrest is pleased to announce achieving ISO13485:2016 certification under the updated regulation, which is the internationally recognized standard for quality management systems in the medical device industry. LCR Hallcrest has demonstrated its ability to produce, sell and service the sales of medical devices while satisfying applicable regulatory requirements.
The updated regulations are more than a revision, they are essentially a new regulation with increased regulatory requirements that strengthen quality systems for medical devices. All processes that are part of the quality system will now be required to utilize a risk-based approach including outsourced processes. This is a significant expansion from ISO 13485:2003, in which only product design controls and product realization processes were subject to risk assessment.
Some of the significant changes within the manufacturer include the appointment of a person responsible for regulatory compliance, defining the skills and experience necessary to manage the quality management system, maintaining new structure and levels of detail for the technical file, and the implementation of the Unique Device Identification system processes and marking.
LCR Hallcrest “Complies with the requirements of
ISO 13485:2016/NS-EN ISO 13485:2016
The Certificate is valid for the following scope:
The Manufacture and Sales of Products Based on Liquid Crystal Microencapsulation & Color Change Technologies for the Medical Industry”
“LCR Hallcrest is the global leader in microencapsulated liquid crystal products and color change technologies for healthcare” comments Rocky Sapienza, V.P. of Operations, “and we see our certification to the updated standard as a demonstration of our continued commitment to furthering the availability of economical color change medical temperature indicators through the unique properties of liquid crystals.”