Kaysun's commitment to excellence is well documented through its certifications, including ISO 13485:2016, IATF 16949:2016, ITAR, and MedAccred Plastics accreditation.
Each certification denotes injection molding expertise within key industries. However, MedAccred places Kaysun in an elite group of medical injection molding companies that can proficiently and confidently serve the medical industry.
Receiving MedAccred Plastics accreditation once is an accomplishment. Achieving recertification three years in a row as a MedAccred manufacturer — as Kaysun has — is remarkable. It unequivocally assures medical OEMs of a consistent focus on patient safety and an unparalleled benchmark of quality standards.
To better understand what makes MedAccred-accredited companies unique and how the accreditation translates to medical device injection molding, let's dig into MedAccred. We'll explore what the accreditation is, what the process entails, and what it means for Kaysun's medical OEM partners.
What is MedAccred?
MedAccred is a medical device industry-managed supply chain oversight program directed by the Performance Review Institute.
MedAccred’s top priority is reducing risk to patient safety through:
- Verifying compliance with critical manufacturing processes
- Improving the quality and consistency of medical devices
Earning accreditation is a rigorous process, and only a small fraction of injection molders are awarded the designation.
Why Did Kaysun Choose to Pursue MedAccred Accreditation?
The medical industry continues to experience rapid organic growth, some of which being partially attributable to the impact of the global pandemic. The speed of change compels medical OEMs to keep pace with product quality and performance standards set by companies participating in MedAccred, including Stryker, Johnson & Johnson, and Medtronic.
Injection molders are in a similar position. Ray Dorow, Kaysun Quality Manager, explains:
"Being a value-added medical OEM partner means leaning into efficiencies that streamline the production process while also surpassing the highest expectations for injection molded parts. MedAccred accreditation signals Kaysun’s recognized ability to accomplish these goals within the medical market and to apply those capabilities during part development for other industries."
What's Entailed in the Accreditation Audit Process?
For injection molders producing plastics-based complex medical parts, MedAccred audits are conducted by vetted subject matter experts who apply specific criteria to injection molding, insert molding, overmolding, and other processes. Doing so enables a robust assessment of a molder’s ability to consistently manufacture medical parts that conform to applicable technical specifications, industry standards, and OEM requirements.
In terms of audit specificity, Kaysun was subject to a comprehensive review of procedures, work instructions, training records, and other documentation pertaining to meeting customer specific requirements. Of particular interest to the MedAccred auditors was Kaysun’s continuous improvement practices and their demonstrated commitment to production efficiency and maintaining high standards internally and on behalf of medical OEMs.
Kaysun also applied for, and received, consecutive MedAccred Plastics recertifications. The process entailed additional auditing, identification and completion of corrective actions, as well as review and approval by the MedAccred Task Group Review team.
How Do Medical OEMs Benefit from Working with a MedAccred Accredited Molder?
A custom injection molder with MedAccred Plastics credentials is unique in its own right, since so few molders are able to obtain the advanced certification. In the larger scope, MedAccred accreditation indicates that the injection molder has proven expertise helping medical manufacturers:
- Maximize vendor partnerships and supply chain management
- Adhere to stringent process and product requirements
- Improve product quality and reduce the potential for recalls and warranty claims
- Reduce overall patient risk and limit medical OEM litigation/liability exposure
Medical OEMs turn to Kaysun for injection molding design, engineering, and materials expertise that can streamline project time and costs while consistently prioritizing patient safety. Holding MedAccred Plastics accreditation for more than three consecutive years speaks to Kaysun’s continued commitment to excellence, and gives medical OEMs even more confidence in an already highly regarded medical injection molding partnership.
The complexities of a medical device injection molding project raise plenty of questions during new product development. Collaborating with a MedAccred Plastics accredited molder from initial concept through final production is beneficial — and necessary. Find out why by downloading our tip sheet, From NPD to Production: Tips for Successful Medical Injection Molding. Click the button below to access your copy now.