PTI Engineered Plastics

PTI Engineered Plastics recently announced that MedAccred has recognized it for its commitment to continual improvement in medical device quality.

The Macomb, Michigan–based company’s MedAccred accreditation follows a successful audit. MedAccred found that the medical device contract manufacturer demonstrated an ongoing commitment to quality by satisfying customer requirements and industry specifications.

The nonprofit Performance Review Institute administers the MedAccred program. Its EVP and COO Jay Solomond said MedAccred accreditation has global recognition as a hallmark of quality and is a major accomplishment.

“The medical device industry has incorporated MedAccred into its approach for handling risk, as it demonstrates compliance to industry standards and customer requirements. I am delighted, therefore, that PTI Engineered Plastics has achieved MedAccred accreditation for Plastics, and that all their hard work has paid off,” Sol…

By PTI Engineered Plastics

Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) guidelines. IQ/OQ/PQ certifies the necessary equipment is present and the manufacturing process to create devices that consistently perform to the desired specifications. Several key areas with specific criteria are critical to the process, yet they are often overlooked or underestimated.

Material Selection:

First and foremost, availability is a key factor when it comes to material selection for a medical device. It is important to choose a material that is widely available in the market in wh…