Bedford, NH --
Sunrise Labs, a medical device product development firm in Bedford, NH, is pleased to announce that they’ve received the FDA regulated certification of the revised ISO-13485:2016 Standard, which emphasizes a risk management based approach. Sunrise Labs first achieved ISO-13485:2013 certification in 2015. Alignment with the latest standard reflects their ongoing commitment to quality.
"At Sunrise, we strive for continuous improvements in our technical capabilities, methods, and procedures. Alignment to this newest ISO standard helps ensure the products we develop for clients will comply with worldwide standards." said Eric Soederberg, President of Sunrise Labs.
Specific to the medical device industry, ISO-13485:2016 requires the development, implementation and maintenance of a quality management system by medical device manufacturers and suppliers to ensure product safety, reliability, and quality. Key changes with ISO-13485:2016 requires all software be validated and documented in the quality management system, establishment and maintenance of the technical documentation structured to the clauses of the standard for the technical file and design and development files, and new requirements for complaint handling process.
To prepare for the certification audit, Sunrise organized an internal project team to conduct a gap analysis and to make the transition from the ISO-13485:2003 version. The new standard replaced all other versions after its publication in March 2016, and requires all manufacturers, suppliers, and consultants to meet the requirements by February 2019.