Kaysun's commitment to excellence is well documented through 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 custom injection molders that can capably and confidently serve the medical industry.
Receiving MedAccred Plastics accreditation once is an accomplishment. Being re-certified 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 plastic injection molding medical parts, let's dig into MedAccred. We'll explore what the accreditation is, what the process entails, and what it means for Kaysun medical OEM partners.
What is MedAccred?
MedAccred is a medical device industry-managed supply chain oversight program managed 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 is evolving rapidly, both organically and in response to the urgency surrounding 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 similarly positioned. Ray Dorow, Kaysun Quality Manager, explains:
"Being a value-add medical OEM partner means leaning into efficiencies that streamline the production process while meeting — and exceeding — the highest expectations for injection molded parts. MedAccred accreditation signals Kaysun’s recognized ability to accomplish these goals within the medical market and to translate the production practices into part development for other industries."
What did the accreditation audit process entail?
For injection molders producing plastics-based complex medical parts, MedAccred audits are administered 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 manufacturer 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 requirements. Of particular interest to the MedAccred auditors was continuous improvement practices, which demonstrates Kaysun’s continued focus on production efficiency and high standards within the organization and on behalf of medical OEMs.
Kaysun also applied for and received consecutive MedAccred Plastics re-certifications. The process entailed additional auditing, identification of and completion of corrective actions, and 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 that carries the MedAccred Plastics credentials is unique in its own right, since so few molders are able to obtain the certification. In the larger scope, MedAccred accreditation indicates that the injection molder has proven expertise helping medical manufacturers:
- Make supplier partner selection and supply chain management more efficient
- 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 design and materials expertise that streamlines custom injection molding project timelines and costs while prioritizing patient safety during every project phase. Holding MedAccred Plastics accreditation for three consecutive years instills even more medical OEM confidence and speaks to Kaysun's continued commitment to excellence.
In conjunction with certifications, Kaysun adds value to medical OEM partnerships and supply chains with proven, optimized injection molding solutions. Learn more in our guide, Designing Plastic Parts & Products for Medical Applications. Click the button below to access your copy now.