Coating Services

Reliable Coating Services for Medical Devices

In manufacturing, the last thing you need is surprise or unpredictability. As a reliable, dependable, economical manufacturing services partner, Harland can be one of your greatest assets, freeing up in-house resources and increasing your ability to deliver consistent results to your customers. Our comprehensive coating capabilities undergo regular testing and reporting in accordance with ISO 13485 standards to ensure both the quality of your products and the efficacy of our coating process.

Features

Cost Savings

Faster time to Market

Faster Time to Market

ISO icon

ISO 13485 Quality System

Coating Know How

Coating Know-How

Scale Production

Ability to Scale Production

Support Services

Support Services Immediately Available

Harland’s Coating Services Approach

Initialization

To begin we gain a clear understanding of your device surface characteristics and properties.

Validation

We then use statistical methods and design of experiments to identify the process limits for coating your device. After that, a statistically driven operational qualification, followed by a process qualification helps ensure the process produces coated devices that meet your specification.

Incoming Inspection

Following a previously agreed upon inspection plan, Harland receives, documents and warehouses each incoming lot of materials.

Raw Material Sourcing

We offer efficient sourcing of raw materials that conform to your specifications, helping to optimize the efficiency of your critical supply chain.

Warehousing

We provide warehousing solutions for uncoated sub-assemblies or finished products, helping you to manage in-process inventory.

Coating Service

From surface preparation to device fixturing, coating and curing, Harland’s integrated coating services deliver consistency and excellence through all stages of formulation, testing, application and volume production. Our skilled technicians can handle any commercial or in-house coating challenge, and all services are performed in compliance with our ISO13485 certification.

Inspection, Testing & Quality Assurance

Based on the quality and performance criteria for your product, we can inspect and test for a variety of coating parameters, including surface coverage, thickness, lubricity and durability.

Documentation

Harland establishes and implements written procedures to ensure that device history records are maintained in accordance with the Device Master Record (DMR), including information on incoming material acceptance, manufacturing processes, manufacturing dates and quantities, quantities released for distribution and acceptance records.

Coating Validation
Medical Device Inspection
Using Coater

WHITE PAPER

10 Essentials for a Hydrophilic Coating Program

10 essential elements to consider when selecting a coating program for medical devices such as catheters, guidewires, introducers and other devices.

DOWNLOAD

All of Your Coating Needs in One Place

Every medical device is unique and bringing it to market is a major challenge. That’s why Harland’s Coatings 360 approach tailors a complete answer to your distinct product coating needs and goals. We’re the industry’s only comprehensive source for high-performance coatings, equipment and production coating services—everything you need to coat your medical device on time and within budget. We provide it all in-house, so when you partner with us, you have one resource for everything coatings.

Learn More
Coatings 360 Logo