Healthmark Industries announced that it has received ISO 13485:2016 certification. ISO 13485:2016 is designed to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery of medical devices that are safe for their intended purpose.
In other news, Malinda Elammari is a new clinical education specialist for Healthmark Industries. She will provide clinical expertise on medical device processing, SPD education and standards.
Prior to joining Healthmark, she has had over 20 years of experience as a central services and surgical tech professional. Most recently responsible for sterile processing education and quality control management at Duke Raleigh Hospital, where she was interim director of education and quality. Elammari primarily focused on planning, developing and staff training programs. She was responsible for providing continuing education to ensure the SPD staff remained certified and were conversant about the latest trends and requirements of a sterile processing area. She also had responsibility for analyzing training needs, quality process implantation and oversight and modifying as needed to improve programs. She also was a central sterile instructor at Durham Tech Community College for five years.
Elammari is a Certified Sterile Processing Manager, a Certified Endoscope Reprocessor, currently serves as a president of an IAHCSMM local chapter, SSGB-Lean six sigma green belt and serves on numerous AAMI Committees.
Visit www.hmark.com for more information.
