ProMed’s Quality Processes
ProMed’s Quality Assurance is dedicated to delivering silicone and thermoplastic components and assemblies of the highest quality for medical products. To ensure that components consistently meet quality standards and comply with federal regulations, a robust quality system was developed.
Our development engineers can partner with you and provide feedback to optimize key features that will yield a highly capable manufacturing process. We develop and validate every process to ensure its repeatability. After product release, we maintain strict process controls using a continuous improvement program that ensures success for years to come.
ISO Registration and FDA Compliance
We are an approved, certified supplier to many of the top medical device manufacturers in the world. All ProMed facilities go through routine audits by our ISO registrars and customers, demonstrating our robust quality system that is ISO13485-2003 certified and FDA 21 CFR 820 compliant.
Quality at ProMed is an integral part of our manufacturing process and company culture, as is evident through our Quality Policy:
ProMed Molded Products, Inc. is committed to manufacturing quality products and serving the needs of our customers. We strive to provide products and services that meet requirements, are delivered on time, and priced to provide superior value. This fundamental practice ensures products consistently meet both customer and ProMed quality standards. All products are manufactured according to our Quality System which is reviewed and supported by Management.
ProMed‘s quality commitment is part of our culture. Our processes are developed using scientific methodology, controlled statistically, and continuously improved systematically using the DMIAC approach. All of your parts are manufactured in Class 10,000/ISO 7 Class cleanrooms and supported by a robust quality system that is ISO13485 certified.