Elcam Medical Receives MedAccred Certification for Plastic Injection Moulding Processes
Elcam has recently received the MedAccred accreditation for plastic injection moulding processes for its Israeli sites, and has become the first company in Israel to be awarded this accreditation.
MedAccred is an industry-managed, consensus-driven approach for ensuring critical manufacturing process quality throughout the medical device supply chain. In today’s world of global manufacturing, the supply chain is multi-tiered and geographically remote, making oversight challenging and costly. To prevent output deficiencies, critical processes and products must be validated during manufacturing to prove that they are fit for purpose, satisfy customers’ and regulatory requirements and reduce overall risk.
The MedAccred accreditation is unique because it is industry-driven and managed. Its subscribers are top-tier medical device companies such as Bausch Health, Baxter, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker. These companies fund and manage MedAccred, determine audit criteria, have full access to audit findings, and determine who is granted accreditation.
Israel Dembus, Elcam’s Chief Quality and Regulatory Officer, shared: “Elcam decided to obtain the MedAcrred accreditation based on our understanding that this accreditation is a growing trend in improving the medical device industry quality standards, which 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.”
Elcam intends to continue the accreditation process and to receive accreditation for all applicable production processes in all worldwide sites during the next two years.