Techam Solutions is proud to announce that we have successfully achieved Medical Device Single Audit Program (MDSAP) and ISO 13485 internal audit certification, reinforcing our commitment to quality and regulatory compliance in the medical device industry. This accomplishment strengthens our compliance practice, allowing us to provide even greater value to our clients.
With over a decade of experience in quality management system (QMS) implementation and maintenance, we have worked with multiple companies to achieve and sustain ISO 9001 and AS9100 certifications. Our expertise in regulatory compliance and operational excellence positions us as a trusted partner for medical device manufacturers seeking to improve their quality systems and streamline their operations.
MDSAP enables medical device manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple countries, including the U.S., Canada, Brazil, Japan, and Australia.
ISO 13485 is the internationally recognized quality management system standard for medical device manufacturers, ensuring compliance with regulatory and customer requirements.
With these certifications, we are expanding our customer base in the medical device sector, particularly focusing on providing superior service to clients in and around Kansas. Our goal is to help medical device manufacturers achieve compliance, optimize processes, and maintain the highest standards of quality.
For more information on how Techam Solutions can support your medical device operations, contact us today.