Quality & Regulatory

Drake Medical Plastics is ISO 9001:2015 certified and is an FDA registered device manufacturing facility and conforms to ISO 13485.  All products are provided to our customers with certifications at no additional charge. Drake Medical ISO Certification.

Drake Medical Plastics manufactures using process monitoring and control systems. Our process equipment is designed specifically for producing the highest quality high performance polymers consistently and efficiently. Drake Medical Plastics embraces and employs lean business practices and manufacturing techniques. We produce in single piece flow, work to eliminate waste and inefficiency, and strive for perfection in all we do and deliver.

Qualification & Validation

Drake Plastics Medical has established its quality system to meet the rigors of FDA 21 CFR part 820, EU regulatory bodies, and other regulatory bodies as needed by our customers.  All our employees are focused on providing quality products and services.  We understand the criticality within the medical industry of providing good products every time.

Whether we are making a stock shape or a finished medical device, our systems provide clear traceability from the batch of resin to the finished product.   From beginning to end, we document the details that are critical to providing confidence that the product will be produced the same way every time.

We work with our customers to define responsibilities and authorities so that all regulatory requirements are clearly met.

Quality Policy

DRAKE MEDICAL PLASTICS PURSUES PERFECTION IN THE PRODUCTS WE PRODUCE AND THE SERVICES WE RENDER.

At regular intervals, we will review our quality system and objectives. Changes will be made as necessary to ensure compliance with requirements and maintain the effectiveness of the system.

Resources to solve problems and meet our quality objectives will be allocated with utmost urgency.

Click here to view Quality Policy.