Quality

ProMed is committed to the manufacturing of unique, high-purity, silicone and plastic components and assemblies for medical device, combination device, aerospace & defense and other critical applications within highly regulated industries. We serve the needs of our customers by providing products and services which consistently conform to both their internal expectations as well as meeting the regulatory requirements for the industries they operate within. ProMed’s management team is committed to continually improving the effectiveness of our Quality Management System, and ongoing continuous improvement initiatives have been imbedded into our culture. These standards of service ensure our products consistently meet the exacting quality standards of the industries that we proudly serve.

Compliance With Industry Regulations

ProMed’s Quality standards comply with the regulations for the industries we support and the global regions that we service. Please contact our Quality Team for a formal response to any of the following regulations:

  • Latex Free Declaration
  • RoHS Compliance Declaration
  • CFSI Policy
  • BSE/TFE Free Policy

ISO Certification, FDA Registration, ITAR Compliance and Company Policy

ProMed facilities comply with ISO registrars and federal registrations. With our ISO 13485:2016 certification, FDA 21 CFR 820, 210/211, and part 4 compliance, we are well positioned to support the industry requirements that our customers expect. By complying with these regulations, we ensure that we test our manufactured products to meet or exceed our customer expectations.

ProMed Pharma LLC is registered with the US FDA. ProMed Molded Products Inc is an ITAR compliant company.

Quality Commitment and Processes

ProMed’s Management Team is dedicated to maintaining the effectiveness of our Quality Management Systems, and ensuring that all personnel are trained, qualified and competent to fulfill their unique job duties and tasks. We encourage our employees to embrace and practice quality in every step towards manufacturing our products. Employees are encouraged to continuously pursue professional growth and development, as enhancing their skills is critical to maintaining the quality of our products and services.

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