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
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
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.
* * * * *