DesignPlex Biomedical, a TechFW client that specializes in the design and manufacture of medical devices, has received ISO 13485:2016 certification for its Quality Management System.
The scope of the certification covers design, development and manufacturing of medical devices, including active implantable medical devices for mechanical, electrical and related software for use in the cardiovascular system.
“Becoming certified is an exciting milestone for our company because it provides many great opportunities to create more sophisticated cardiovascular devices that will ultimately help to improve the quality of life for patients,” said Robert Benkowski, CEO of DesignPlex Biomedical and Assistant Professor of Medical Education at TCU and UNTHSC School of Medicine.
DesignPlex Biomedical partners with organizations and entrepreneurs to turn ideas into prototypes and turn prototypes into commercial products to aid in bringing new technology to market.
Benkowski explained what ISO 13485:2016 certification means for customers. “(It) is a global standard and certification that helps provide assurance for the formation of a robust design history file and is inherent in how we develop products in a risk based approach. It also means that any product manufactured will have the traceability, repeatability and quality that is demanded for Class III devices.”
DesignPlex’s capabilities help at any stage of developing a medical device, from the product definition and prototyping to detailed design and, ultimately, to manufacturing a clinical product. In its 11,000-square-foot facility is an engineering Design Studio with 3D printing, dedicated electronics assembly area with ESD flooring, machine shop, mechanical assembly area, polymer room and QA/QC offices.
The firm’s specialties include FDA Class II and III medical devices; drug/device combinations; products with electrical, mechanical, pneumatic and software development; artificial hearts and ventricular assist devices; web-enabled products; and remote monitoring with patient and clinician portals.