ISO 13485

Why ISO 13485 Matters When Choosing a Medical Device Component Supplier

Quality isn’t a final step—it’s the foundation of our entire process.

In recognition of World Standards Day, we’re highlighting the standards and quality

processes behind every coated component we manufacture at Applied Plastics.

Backed by more than 70 years of precision coating experience, technical expertise,

proprietary technology, and a skilled workforce, we manufacture PTFE coatings for fine

wire, mandrels, and metal tubing with the consistency and performance demanding

medical device applications require.

As an ISO 13485:2016-certified supplier, quality is integrated into every stage of our

manufacturing process. From incoming inspection of raw materials to our precision

coating processes to in-process quality controls and final inspection, our Quality

Management System helps ensure every coated component consistently meets defined

specifications and customer requirements.

For medical device OEMs and contract manufacturers, this means working with a

coating supplier that has well-established quality processes to support consistent,

reliable components from prototype through production.