Major OEMs in the medical device industry have extended the MedAccred program to benefit contract manufacturers and enable better oversight of their sub-suppliers. The program was developed by medical device company MedAccred Subscribers Bausch Health, Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips Healthcare, Roche Diagnostics and Stryker.
The Contract Manufacturer Subscriber program will build on the current MedAccred program and provide rigorous oversight of critical manufacturing processes conducted by subject matter expert auditors around the world. The critical manufacturing processes addressed by MedAccred continue to expand and currently include cable and wire harnesses, heat treatment, circuit board assembly, plastic extrusion, plastic injection molding, assembly mechanics of plastics, sterilization, packaging of sterile devices and welding.
Subcontractors will benefit from the following advantages:
- Reduced costs while delivering better quality
- Improved process control down to the medical device supply level
- Enhanced role as a strategic supplier with greater assurance of lower tier supplier controls, contributing to improved product quality and patient safety
Dannette Crooms, Vice President, Global Supplier Quality, Edwards Lifesciences, says, “The creation of a new MedAccred contract manufacturer subscription program is an exciting development that will help contract manufacturers in the medtech sector develop greater oversight and control over their supply chains. This innovation will go a long way in supporting quality and patient safety across the medical industry. »
Tony Knight, ssuperior Director, Global Supplier Qquality (CM/OEM), Medtronicadds: “C.subcontractors are now able to leverage the power and reach of MedAccred. This extensive MedAccred CM subscription program is introduced by leading OEMs in the medical device industry. the MedAccred in-depth process audits and the resulting MedAccred accreditations will lead to the improvement of product quality and cost savings through the levels of the subcontractor supply chains. »
Connie ConboyDirector, MedAccred, concludes, “Contract mManufacturers and their subcontractors are responsible for more than 70% of the manufacturing of all medical devices. The complexity of the supply chain across its many layers poses a risk to product quality and patient safety, that’s what the new contract manufacturer subscription program seeks to solve. »