Elcam Medical has become the first company in Israel to achieve the MedAccred Accreditation for Plastics Injection Moulding, meeting the stringent audit requirements set by MedAccred subscribing members.
The MedAccred audit and accreditation programme is unique as the sole industry-managed supply chain oversight programme 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.
Bob Lizewski, vice president, MedAccred, said: “MedAccred Accreditation is globally recognised as conveying quality and is a major accomplishment. 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 Moulding.”
Igal Kohn, chief executive officer, Elcam Medical, commented: “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.
“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 standardise 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.”
Israel Dembus, chief quality and regulatory officer, Elcam Medical, added: “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.”