Quality & Regulatory

Genesis supports customers’ ability to bring medical products to market with our ISO 13485:2016 and ISO 9001:2015 certification and FDA registration as a device manufacturing facility.

Genesis Medical Plastics’ Quality Standards

Genesis Medical Plastics is certified to ISO 13485:2016 and registered with the FDA as a device manufacturing facility. We are also certified to ISO 9001:2015.

Our production operations convert our customers’ implantable PEEK and other medical polymers into extruded stock shapes, calendered film and injection molded components for medical devices. We also precision machine medical device components under strict quality management practices from the stock shapes we extrude for customers.

All products are provided to our customers with Certificates of Conformity at no additional charge.

Genesis’ extrusion, calendering and injection molding technologies employ process control and monitoring technology developed specifically for transforming medical polymers into products with consistently high quality.  In these melt processing operations as well as in our machining facility we adhere to lean business practices and manufacturing techniques for optimum efficiency. Our drive for perfection in everything we manufacture and deliver is characterized by our single-piece flow production that focuses on eliminating waste and inefficiency.

Qualification and Validation

Genesis Medical Plastics understands that bringing medical devices to market requires working within robust systems that ensure all manufacturing processes yield consistently high-quality products. Accordingly, we are committed to giving customers the confidence that their products will be produced the same way every time. We work with customers to clearly define expectations, responsibilities, and quality and regulatory requirements for every product we manufacture for them. 

In addition to our ISO 13485:2016 certification, our quality system meets the requirements of FDA 21 CFR part 820. We also support compliance to EU as well as other regulatory bodies that our customers may require.  To further support bringing their medical devices to market we offer validation services to qualify that our processes produce consistently high-quality parts.

Genesis Medical Plastics’ quality system provides clear traceability from the resin lot to the finished product. Employees in every Genesis operation understand medical device manufacturers’ need for uncompromised quality in the products we manufacture for them.

Quality Policy

Genesis 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 to maintain effectiveness of the system.  Resources to solve problems and meet our quality objectives will be allocated with utmost urgency.

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