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About Importance of ISO 13485 for Medical Plastic Materials & Components Suppliers


Regulatory requirements demand making sure that Medical Device Manufacturers take responsibility for every supply-chain link to meet Good Manufacturing Practices.

Medical Polymers and Components: Quality Requirements

Plastics Materials & Components used for medical applications need consistent performance, including resistance to sterilization, chemicals and lipids. They often must also meet standards for biocompatibility and toxicity, where even slight changes in the ingredients in the plastics used could affect the acceptability of the finished device. Regulatory authorities require that the plastics are “well-characterized” with detailed information on the material ingredients and formulation, manufacturing processes, and extensive supporting data with respect to physical and mechanical properties, biocompatibility and toxicity.

Any material or formulation change over the lifetime of the product, and at any point in a sometimes highly complex supply chain, can invalidate previous approvals.

Importance of ISO 13485

This is why ISO 13485 certification is becoming more and more important. ISO 13485-2016 is the standard governing organizations involved in the design, production, and installation and servicing of medical devices. If upstream suppliers, like plastics processors, are also certified to the standard, they provide their customers with the assurance that they have invested in and understand the medical-device risk-management principles that are core to the standard. Also, that quality control and testing procedures have been applied to the raw materials they use in the components they provide and that they have the documentation to prove it.

Materials & Components suppliers should have a thorough understanding of the end-use application requirements, medical-device regulations that OEMs must meet, risk-management practices, and they will have put change-control measures in place. Usually this involves enhanced GMP and probably certification to an advanced quality standard such as ISO 13485-2016.

Colorants and additives must also be just as tightly controlled as the polymer. They are often subject to frequent changes, both major and minor ingredients such as pigments, stabilizers, plasticizers, lubricants etc. Careful sourcing procedures at each level of the supply chain are increasingly necessary to ensure that materials come with the necessary assurances, and that controls are in place.

The regulatory compliance and quality of a medical device is only as good as its weakest link.

In medical plastics processing, it’s all about minimizing risk.

Suppliers need to make sure there’s no chance a patient might have an adverse experience caused by some defect or oversight. Therefore, the companies supplying materials / components need to be vigilant to make sure actions they take don’t compromise the performance or safety of the final product.


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