Quality, Certifications and Regulatory Status

Genesis Medical Plastics operates a quality system certified to ISO 13485:2016 and ISO 9001:2015 at an FDA registered site in Cypress, Texas. Conversion processes carry IQ, OQ and PQ validations, and Genesis PEEK stock is ASTM F2026 compliant. This page exists for the sourcing manager or quality engineer running supplier qualification, and it is written to answer the questions a qualification package asks rather than to describe the company.

What Is the Scope of Genesis's ISO 13485:2016 Registration?

Finished medical device components produced under an ISO 13485 quality system
Components released under ISO 13485:2016 with documented process validation.

What the page will say once confirmed: the certificate number, the issuing registrar, the current expiry or surveillance date, and the scope statement verbatim.

What Does an FDA Registered Site Mean?

Traceable polymer stock shapes with documented conversion history
Traceability starts at the resin lot and follows the part through every conversion step.

Genesis Medical Plastics is an FDA registered establishment. Registration means the facility is listed with the FDA as an establishment engaged in the manufacture of devices or device components, and that it is subject to FDA inspection.

Registration is not clearance and it is not approval. No material and no component carries FDA approval or FDA clearance, and no supplier can confer either status on a customer’s device. Clearance and approval attach to a finished device through the 510(k) or PMA pathway, and they are held by the device manufacturer, not by the converter.

This distinction is stated plainly here because it is frequently blurred in supplier literature, and a sourcing team that is doing its job will check whether a supplier states it correctly.

What Process Validation Documentation Is Supplied?

High performance polymer rod stock held for medical conversion
Material control is the part of quality a drawing never shows.

Genesis conversion processes carry installation qualification, operational qualification and performance qualification, IQ, OQ and PQ.

How Is Material Traceability Handled?

Traceability is the reason a converter’s quality system matters as much as its machining tolerance. A component that meets the drawing but cannot be traced to a documented resin lot and a documented conversion process is a problem in an audit, whatever its dimensions.

What Certifications Should an OEM Look For in a Polymer Converter?

A sourcing team qualifying a converter for a medical program should expect to see, at minimum:

  • **A medical device quality management system**, ISO 13485, rather than ISO 9001 alone. ISO 9001 is a general quality management standard. ISO 13485 adds the device specific requirements, including design controls, risk management and traceability expectations.
  • **FDA establishment registration**, where the component is destined for the US market.
  • **Documented process validation**, IQ, OQ and PQ, on the specific processes used to make the part rather than on the plant in general.
  • **Material compliance to the relevant standard**, for example ASTM F2026 for implantable PEEK stock shapes.
  • **Biocompatibility test data**, evaluated under the ISO 10993 series, held at the level appropriate to the material and the device contact type.

Genesis holds ISO 13485:2016 and ISO 9001:2015 certification, is an FDA registered site, runs IQ, OQ and PQ validated processes, and supplies ASTM F2026 compliant PEEK stock.

On ISO 10993: biocompatibility testing is performed on materials and finished devices under defined contact conditions, and results belong to the party that commissioned them.

Certificates and Documents

  • ISO 13485:2016 certificate
  • ISO 9001:2015 certificate
  • FDA establishment registration confirmation
  • Material compliance statements by grade
  • Process validation summaries

Talk to Our Engineers About Supplier Qualification

Send a qualification package or an audit request and Genesis will respond with the certificates, validation documentation and material compliance statements the program requires. Contact Our Experts, or call 281-255-6848. 14863 Grant Road, Cypress, Texas 77429.

FAQs for

Yes. Genesis holds ISO 13485:2016 certification, alongside ISO 9001:2015.

No supplier holds it, and neither does any material. Genesis Medical Plastics is an FDA registered site, which means the facility is listed with the FDA and subject to inspection. FDA clearance and approval apply to finished devices through the 510(k) and PMA pathways and are held by the device manufacturer.

ISO 9001 is a general quality management standard. ISO 13485 is written for medical devices and adds requirements covering design controls, risk management, traceability and documentation appropriate to regulated device manufacture. Genesis holds both.

Conversion processes carry IQ, OQ and PQ validations.

Genesis PEEK stock is ASTM F2026 compliant.

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