Editor: What To Know
- 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.
- The assessment uses criteria established directly by customers and experts across the industry, and it is a great way to demonstrate our commitment to our customers' needs.
- 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.
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. We’re currently pursuing accreditation at all of our medical device facilities, and we expect them to be certified in the near future.
”According to Mr. Peavy, Technimark sees the MedAccred program as beneficial for patients, customers and the company. “The accreditation helps us further demonstrate our expertise as a trustworthy and high-quality supplier in the medical device industry. The assessment uses criteria established directly by customers and experts across the industry, and it is a great way to demonstrate our commitment to our customers’ needs.”
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.
