ADS Biotech Receives ISO 13485:2016 Quality System Certification

ADS Biotech, a member of Bio Nebraska, announced that the company has received certification of its quality system to the ISO 13485:2016 standard, for Medical Devices.

Press Release from ADS Biotec

ADS Biotec, a global leader in development of automated instruments and bio-consumables including buffers for mRNA purification, is pleased to announce that the company has received certification of its quality system to the ISO 13485:2016 standard, for Medical Devices. This ISO certification indicates that the company’s quality management system adheres to the most current regulatory requirements specific to the medical device industry.   The scope of the certification includes design, manufacture, distribution and service of in vitro diagnostic automated instruments and accessories for genetic and molecular diagnostic testing.  The scope also covers contract design and manufacture of buffers, reagents and consumables for medical devices and for in vitro diagnostic use.   

” We are very proud of receiving this ISO 13485 certification as it demonstrates the strategic commitment of our entire organization to quality, and to meeting customer’s and international regulatory expectations”, said David Hild, Sr. Vice President and GM of ADS Biotec.  “With total focus and a continuous commitment to quality, we are dedicated to expanding our quality system and regulatory acumen to meet market access requirements in the evolution of regulatory jurisdictions”.

” As a company, we strive to achieve the highest standards in term of innovation and quality”, said Vijay Dube, President and CEO of ADS Biotec.  “This certification, spearheaded by our QA team, is a collective achievement of all of the employees at ADS Biotec. With this certification, we want to send a clear message to our customers and partners, positioning our company as a trustworthy and reliable supplier”.

The ISO 13485:2016 standard is based on ISO 9001:2008 and specifies the requirements an organization needs to demonstrate in providing one or more stages of the life-cycle of a medical device, which includes the design, development, production, storage, distribution, installation and servicing of a medical device.  This International Standard, through the implementation of a quality management system, is to be complementary to the technical requirements for a product to ensure its safety, regulatory compliance, and performance.