Elcam Medical has become the first company in Israel to achieve the MedAccred Accreditation for Plastics Injection Molding, meeting the stringent audit requirements set by MedAccred subscribing members—including Bausch Health, Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker Corp.
The MedAccred audit and accreditation program is unique as the sole industry-managed supply chain oversight program for key critical manufacturing processes in the medical device industry. The goal is to assure that critical manufacturing processes meet consensus requirements leading to the production of high-quality end products, ultimately enhancing patient safety.
“MedAccred Accreditation is globally recognized as conveying quality and is a major accomplishment,” said Bob Lizewski, vice president of MedAccred. “The medical device industry has incorporated MedAccred into its approach for handling risk, as it demonstrates compliance to industry standards, customer requirements and best practices. I congratulate Elcam Medical for their continued focus and dedication to quality which has resulted in their attaining MedAccred Accreditation for Plastics Injection Molding.”
“Elcam constantly strives to build robust products and processes, aiming to ensure product performance as well as the products’ safety and effectiveness. Receiving MedAccred Accreditation for plastics injection moulding processes at Israel sites, and becoming the first company in Israel to get this accreditation, endorses Elcam’s promise to consistently provide our OEM partners with high-quality reliable products,” Elcam Medical CEO Igal Kohn said. “The MedAccred Accreditation gave us an opportunity to improve our internal processes through methods that are accepted by the leading international medical device companies, as well as an opportunity to standardize processes across our sites and in different territories. Elcam intends to continue the Medaccred Accreditation process and to obtain accreditation for all production processes, in all sites worldwide, during the next two years.”
“Elcam decided to obtain the MedAccred Accreditation based on our understanding that this accreditation is a growing trend in improving the medical device industry quality standards, that will help us better serve our customers and partners. The accreditation validates that we maintain the highest quality standards for our products and, ultimately, helps assure patient safety,” added Israel Dembus, Chief Quality and Regulatory Officer at Elcam Medical.
MedAccred is a medical device industry-managed, critical process supply chain oversight program that reduces risk to patient safety, assures quality products and verifies compliance with requirements. The program is administered by the Performance Review Institute. OEM subscribers fund and manage the accreditation program and determine audit criteria, interview and select auditors, and determine which suppliers are granted accreditation.
The Performance Review Institute (PRI) is a not-for-profit trade association started in 1990. PRI is a global administrator of industry-managed critical process accreditation programs focused on improving process and product quality with collaboration among stakeholders in industries where safety and quality are shared goals.