Quality Assurance/Regulatory and Compliance
To provide contract manufacturing services that meet or exceed the expectations of our customer(s) for quality and workmanship. HPC Medx will provide the resources, competent personnel, and infrastructure necessary to perform these services. HPC Medx will establish, implement, and maintain a quality system that meets the requirements of the referenced standards (QM, Section 2.0 Referenced Standards). HPC MedX will strive to improve our manufacturing capabilities through Management Reviews and Data Analysis. This policy applies to personnel at all levels of the organization.
There are various ways of keeping track of and identifying medical devices including printing, labeling, and marking. We have the expertise and technology to be able to print on difficult substrates and difficult locations while adhereing to stringent regulatory requirements, including the newly reqired UDI (Unique Device Identifier).
We offer a full range of packaging options including packaging design services based on your company’s specifications, and application while adhering to regulatory requirements.