Bluechips Enters Medical Market with ISO 13485 Certification

Bluechips Microhouse is proud to announce that the company officially received the ISO13485:2012 certification. Bluechips is therefore not only capable of developing but also producing medical devices.

A medical device is by definition a product, such as an instrument or machine that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Emphasis of the certification is put on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacturing and distribution of medical devices.

ISO’s 2016 version of the certificate is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations, therefore representing Bluechips striving for constant improvement and the aspiration to stay up-to-date in every area and market.

What are the advantages that come with the implementation of ISO13485:2012?

• Represents a preventive approach in comparison to other, reactive approaches, thus decreasing the likelihood of non-conforming products.
• Reducing costs as a result of minimizing product failures.
• Best quality management practice in the medical device industry.
• Meets regulatory requirements in many countries.
• Creates a systematic framework in which Bluechips monitors, measures and analyzes the processes and customer feedback.

Find out which other Certifications and Accreditations Bluechips Microhouse has to offer, representing the unparalleled approach to quality and customer satisfaction.