Michael Barbella, Managing Editor04.14.23
Flex Medical Molding (Shenzhen) Co. Ltd has become the first site within Flex to earn MedAccred industry-managed program accreditation for Plastic Injection Molding following a recent successful audit.
The Gushu facility in Shenzhen, China, achieved the accreditation after meeting the audit requirements set by MedAccred subscribing members, including Baxter, BD, Boston Scientific Corp., Edwards Lifesciences, Johnson & Johnson, Medtronic plc, Philips, Roche Diagnostics, and Stryker Corp.
“I wish to congratulate Flex Gushu for its commitment to quality which enabled it to attain MedAccred Accreditation for Plastics Injection Molding," MedAccred Vice President Bob Lizewski said. "This is a major accomplishment which is globally recognized. 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.”
The MedAccred audit and accreditation program is the sole industry-managed supply chain oversight program for key critical manufacturing processes in the medical device industry. The accreditation assures that critical manufacturing processes meet industry consensus requirements, leading to the production of high-quality end products, ultimately enhancing patient safety.
“Flex Gushu obtained the MedAccred Accreditation in injection molding process which can help to improve the quality of products and most importantly patient safety. We are the first Flex site to get the certification worldwide in injection molding," stated Keith Hung, vice president for Medical Operations, Asia, at Flex. "MedAccred Accreditation can be used as tool to enhance the process capability, manufacturing monitoring and process validation. We will utilize all resources available in our pursuit of this quality.”
“The MedAccred accreditation gave us the excellent chance to improve the processes through different tools that are recognized by the leading medical device companies, as well as to step up into a new level of quality control in our site. We plan to continue the MedAccred Accreditation process and seek for the improvement in the system and extend to other areas,” Flex Senior Quality Director Kenneth Leung said.
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. MedAccred is administered by the Performance Review Institute, 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.
Flex (Shenzhen) supplies the healthcare industry with capabilities in precision plastics, mechanical design, and manufacturing.
The Gushu facility in Shenzhen, China, achieved the accreditation after meeting the audit requirements set by MedAccred subscribing members, including Baxter, BD, Boston Scientific Corp., Edwards Lifesciences, Johnson & Johnson, Medtronic plc, Philips, Roche Diagnostics, and Stryker Corp.
“I wish to congratulate Flex Gushu for its commitment to quality which enabled it to attain MedAccred Accreditation for Plastics Injection Molding," MedAccred Vice President Bob Lizewski said. "This is a major accomplishment which is globally recognized. 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.”
The MedAccred audit and accreditation program is the sole industry-managed supply chain oversight program for key critical manufacturing processes in the medical device industry. The accreditation assures that critical manufacturing processes meet industry consensus requirements, leading to the production of high-quality end products, ultimately enhancing patient safety.
“Flex Gushu obtained the MedAccred Accreditation in injection molding process which can help to improve the quality of products and most importantly patient safety. We are the first Flex site to get the certification worldwide in injection molding," stated Keith Hung, vice president for Medical Operations, Asia, at Flex. "MedAccred Accreditation can be used as tool to enhance the process capability, manufacturing monitoring and process validation. We will utilize all resources available in our pursuit of this quality.”
“The MedAccred accreditation gave us the excellent chance to improve the processes through different tools that are recognized by the leading medical device companies, as well as to step up into a new level of quality control in our site. We plan to continue the MedAccred Accreditation process and seek for the improvement in the system and extend to other areas,” Flex Senior Quality Director Kenneth Leung said.
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. MedAccred is administered by the Performance Review Institute, 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.
Flex (Shenzhen) supplies the healthcare industry with capabilities in precision plastics, mechanical design, and manufacturing.