![]() "This certification reflects our commitment to delivering high quality state-of-the-art technologies addressing the needs of our customers and ultimately the patients that they serve. Along with all of the free ISO 13485 materials we also offer ISO 13485 document templates, ISO 13485 software, ISO procedure downloads, and ISO 13485 download information that will all help you on the road to certification. "Quality is in everything that we do," said Chuck Kummeth, Bio-Techne's President and Chief Executive Officer. "The implementation of ISO 13485:2016 demonstrates that Bio-Techne and the Cloudz reagents are produced under the strict standards of the medical devices industry," said Dave Eansor, President, Protein Sciences "This certification is an important milestone for our company and reflects our commitment to delivering safe, high-quality products for cell and gene-modified cell-based therapies." To be certified, organizations must demonstrate that their Quality Management Systems are able to provide medical devices and related services that consistently meet customer and regulatory requirements. ![]() ![]() ISO 13485:2016 is an internationally recognized quality standard intended to ensure the consistent design, development, production, installation, and sale of medical devices that are safe for their intended purposes. This achievement provides additional assurances to our customers that critical components for their processes are designed and manufactured to meet their exacting requirements. This certification is widely recognized internationally as a standard for quality management systems related to medical devices and related services. ![]() Each section begins with a policy statementFile Size: 202KB. The manual is divided into eight sections that correlate to the Quality Management System sections of ISO 13485:2016. Bio-Techne's Woburn facility produces Cloudz™ Cell Activation Kits, a magnetic-free bead-based technology for the robust and reliable expansion of immune cells, including T cells and NK cells, representing a pivotal component of the cell and gene therapy workflow. This system addresses the design, development, production, installation, and servicing of the company’s products. 15, 2020 /PRNewswire/ - Bio-Techne Corporation (NASDAQ: TECH), a leading provider of proteins, antibodies and cytokines today announced that its Woburn, Massachusetts site received ISO 13485:2016 certification for Medical Device and Quality Management Systems. Requirements include final decommission and disposal of the medical device’s life-cycle, design and development, production, storage and distribution, installation as well as delivery of medical device or related services that are safe for their intended purpose.MINNEAPOLIS, Oct. ISO 13485:2016 standard defines quality management system requirements for organizations that are involved from initial stage of conception to production and post-production. Therefore, most of the service providers in the medical device industry sector understand the main objectives of ISO 13485, which is to harmonize medical device regulatory requirements for quality management system in order to have a quality medical devices and safe patients. Possibly more than any other type of manufactured product, the quality of medical devices has a direct impact on their work effectiveness as well as the safety of patients, and users. ![]() ISO 13485 is evolving with medical devices to keep pace with modern innovation. This system addresses the design, development, production, installation, and servicing of the company’s products. Medical devices are revolutionizing medicine with breathtaking advances in the detection and treatment of many diseases. 2021.11.25 23:10 > Click Here to Download <<<<< Iso Version Pdf Free Download The new version, ISO, Medical Devices. ![]()
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