True Process Passes ISO 13485:2016 Audit
Milwaukee — June 14, 2018 — True Process Inc., an ISO certified healthcare IT firm focused on medical software engineering for connected medical devices, is proud to announce their recent audit success! True Process is now certified to the new revision (2016) of ISO 13485—an internationally recognized quality management standard for medical devices.
With the ISO 13485 certification, True Process commits to providing products and services that will consistently meet the needs of their customers and follow the regulatory requirements of the medical device industry. True Process’ quality standard states,“True Process is committed to quality and views it as a defining characteristic of our company. Our Quality System exists to ensure that we maintain the highest level of accuracy, reliability, and efficiency in the solutions and products that we offer to our healthcare clients. Compliance with our Quality System policies, procedures, and objectives is mandatory for our team and is achieved through continuous training, evaluation, and improvements.”
At the core of True Process’ approach to delivering client solutions is the flexibility to select and implement delivery methodologies best suited to the client’s needs while remaining faithful to industry standards of excellence. True Process’ Software Engineering Team successfully utilizes the Agile Methodology for software development as a Medical Device (SaMD), while also complying with ISO standards. True Process team members have a high degree of experience and skills critical to exceeding client expectations and successfully implementing a competency-based quality management system.
“Certification to the 2016 revision of ISO 13485 assures our customers that we are able to consistently deliver compliant services within their medical device’s software development life cycle” said Steve Krueger, True Process’ Director of Quality Assurance and Regulatory Affairs.
Looking for a software engineering partner that is ISO certified? Contact True Process, a company that knows regulated software development.CONTACT TRUE PROCESS!