MEXICALI, MEXICO, (August 15, 2024) – Technimark, a global manufacturing leader for the medical market, announced today that their facility in Mexicali, Mexico is now MedAccred Certified in Plastics by the Performance Review Institute (PRI). Providing rigorous qualification for medical devices, the Performance Review Institute offers MedAccred certification through industry managed and approved standards to ensure critical manufacturing quality for medical devices. 

Bolstered by increased investment in additional cleanrooms and increasing the size of the facility, Mexicali marks the fourth plant that is MedAccred certified following our facilities in El Paso, Texas, Latrobe, Pennsylvania, and Longford, Ireland. Adding another MedAccred certified location to demonstrates Technimark’s commitment to standards developed by medical device OEMs, contract manufacturers, and suppliers. The MedAccred certification evaluates five distinct areas of focus including:

• Consistent and standardized process 
• Subject matter experts on-site
• Greater supply chain visibility
• Ensuring the easy transfer of knowledge to sub-tier suppliers
• Applying industry-accepted and consistent technical requirements to production

In addition to the certification of the facility in Mexicali, Technimark is seeking further accreditation of two other locations by 2025. 

“Obtaining MedAccred and other industry certifications are essential to demonstrate our commitment to excellence,” stated Kris Peavy, Chief Commercial Officer, and President of Healthcare at Technimark. “We want our customers to know our commitment is to the highest manufacturing standards in the industry.”

Achieving these rigorous standards throughout a thorough and complex audit process demonstrates Technimark’s commitment to the continued improvement and enhancement of medical manufacturing. By adhering to the highest manufacturing standards throughout our global facilities, we provide quality and performance assurances for customers and consumers across the world. 

About Technimark

Technimark is a global manufacturing solutions provider for the healthcare, consumer packaging, and specialty industrial market. Technimark specializes in precision injection molding, value-added assembly, and full supply chain services. Technimark provides clients with customized, end-to-end solutions based on technology and innovation that improve quality, reduce risk, lower costs, and speed products to market. With facilities in the United States, Mexico, United Kingdom, Ireland, Germany, and China, Technimark delivers high-quality products worldwide. For more information, visit technimark.com.

Company currently pursuing new industry standard MedAccred certification for its other medical device facilities worldwide

ASHEBORO, N.C. (Jul, 6, 2021) – Technimark announced today that its production facility in El Paso, Texas, received its MedAccred certification from the Performance Review Institute. The facility, which is also ISO 13485:2016 certified and 21 CFR 820 compliant, specializes in medical contract manufacturing, including services such as custom injection molding, assembly and logistics operations for the medical device industry.

“Patient safety and quality are our highest priorities, and we are excited to partner with MedAccred to ensure our critical processes are best-in-class,” said Kris Peavy, president of Technimark’s Healthcare division. “The significant growth of our medical device business around the world, and specifically in our El Paso facility, made MedAccred certification a perfect fit. The accreditation helps us further demonstrate our expertise as a trustworthy and high-quality supplier in the medical device industry.  We’re currently pursuing accreditation at all of our medical facilities, and we expect them to be certified in the near future.”

The MedAccred certification program was developed by the Performance Review Institute, a non-for-profit organization that facilitates collaborative supply chain oversight programs, quality management systems approvals and professional development activities in industries that rely on high-quality, high-safety protocols. MedAccred is managed by the medical device OEMs, contract manufacturers and suppliers who collaborate to provide the sector with a trustworthy, evidence-based tool to ensure the suppliers’ processes and products meet the highest standards and improve product quality.

“Technimark is clearly committed to quality and improving patient safety by meeting the rigorous requirements set by technical experts in the medical device industry,” said Connie Conboy, director, MedAccred. “Technimark is a true leader in the medical device industry as demonstrated by their MedAccred Accreditation for Plastics Injection Molding at their El Paso, Texas facility.”

In describing the MedAccred certification process, the Performance Review Institute notes that preventing output deficiencies requires that critical processes and products be validated during manufacturing to prove that they are fit for purpose, satisfy regulatory requirements and reduce overall risk. The MedAccred certification does just this by:

• Providing consistent, standardized critical process accreditation accepted by the Medical Device Industry resulting in fewer redundant onsite audits by multiple OEMs
• Having Subject Matter Experts conduct in-depth critical process audits that are compliant and consistent with accepted industry/technical standards
• Providing greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g., FDA, ISO 13485, MDD/MDR, etc.)
• Improving the flow down of OEM requirements to sub-tier suppliers
• Applying medical device industry-accepted and consistent technical requirements that yield process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost

Mr. Peavy explained that the audit is very thorough and drills into each individual process under review. “While MedAccred certification requires an ISO-certified quality management system, the process is not simply a QMS audit. Rather, it focuses on the key elements of the manufacturing process itself,” he said.

Audits are conducted by industry-approved and trained SME auditors on behalf of its subscribing OEM members using collaboratively created audit criteria. The accreditation is granted and accepted by the program’s subscribing OEM members. The audit criteria incorporate industry-accepted performance standards and manufacturer specifications that meet regulatory requirements.

“On behalf of Technimark and our clients, I want to thank the entire El Paso team for leading the way on this notable achievement,” Mr. Peavy said.

About Technimark

Technimark is a global manufacturing solutions provider for the healthcare, consumer packaging and specialty industrial market. Technimark specializes in precision injection molding, value-added assembly and full supply chain services. Technimark provides clients with customized, end-to-end solutions based on technology and innovation that improve quality, reduce risk, lower costs and speed products to market. With facilities in the United States, Mexico, United Kingdom, Ireland, Germany and China, Technimark delivers high-quality products worldwide. For more information, visit technimark.com.