Manufacturing Services

Reliable Coating Services for Medical Devices

Predictable results are a significant factor when considering outsourcing.
In manufacturing, the last things you need are surprises or unpredictability. A reliable and dependable manufacturing partner can be one of your greatest assets, freeing up in-house resources so you can concentrate on your core technologies and increasing your ability to deliver consistent results to your customers.

As a highly specialized contract manufacturer, we develop processes that are efficient, reliable, and offer cost savings. We perform regular testing and reporting to ensure that you have a clear view of the manufacturing process and the quality of your product.

Incoming Inspection
Following a previously agreed upon inspection plan, we will receive, document and warehouse each incoming lot of materials.

Raw Material Sourcing
Harland offers efficient sourcing of raw materials that conform to your specifications helping optimize the efficiency of your supply chain.

Coating Services
Harland offers fully integrated coating services.  From surface preparation to device fixturing, coating and curing, our skilled technicians deliver results.   And Harland Coating Services can handle any commercial or in-house coating technology.   All Coating Services are provided in compliance with our ISO13485 certification.

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

Sterilization Services
We coordinate all aspects of sterilization including sterilization validations quarterly dose audits, annual ETO re-qualifications and routine processing.

We use only ISO certified processors and provide certificates of processing with each shipment. We can help you select materials for your products which will allow you to use a preferred method of sterilization.

Warehousing and Delivery
We provide warehousing solutions for coated sub-assemblies or finished products, allowing you to manage your inventory off-site so you can devote your own space to what you do best. We can even work with you to coordinate shipments to your end users.

We establish and implement written procedures to ensure that device history records are maintained in accordance with the Device Master Record (DMR) including information on incoming material acceptance, the manufacturing process, dates of manufacture, quantities manufactured, quantities released for distribution and acceptance records.