FOR IMMEDIATE RELEASE:
SPE Medical Obtains ISO 13485 Certificate of Registration
Sarasota, Florida – June 2, 2010 - Today BSI Management Systems America, Inc. issued Certificate Number FM 550271 to SPE Medical, Inc. for compliance to ISO 13485:2003, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
“Our certification to ISO 13485 validates our commitment to providing global health care markets with safe and effective medical device solutions that meet our customers’ requirements. SPE Medical is in a unique niche position within its business segment because of the complete offering of related services to our customers. We have the knowledge and capabilities to develop, design, and manufacture devices. We can design, build, maintain and repair our injection molds with the resources within our facility,” says, Michael Ontiveros, Co-Founder.
Sarasota Precision Engineering Medical, Incorporated (referred to as SPE Medical) is a privately held Florida corporation located at 2305 72nd Avenue East in Sarasota, Florida. Within the facility, ISO 14644-1 certified cleanrooms to ISO Class 6, ISO Class 7 and ISO Class 8 provide the operational environment for injection molding of medical grade liquid silicones and assemblies of medical devices and components.
SPE Medical is a new business unit within a portfolio of companies owned by Doug Mansfield.
These companies serve the moldmaking and plastic injection molding of both thermoplastic and liquid silicone rubber for the Aerospace, Automotive and Medical markets. “Customer service has always been our corner stone to success. Once we commit ourselves to a project we employ all of our experience, knowledge and resources into the best value for our clients. As an example, one of our aerospace accounts brought us a component that needed repair from years of use. After our team reviewed all the requirements, we recommended an engineering change that yielded a substantial part cost reduction and provided improved performance. It’s this type of service that builds partnerships with our customers,” says, Mr. Mansfield.