Contract Services for Medical Device Assembly and Packaging
QTS delivers outsourcing solutions that address the critical phases in the medical device development and production cycle. Whether it is a few phases in the project cycle or the entire project, Quality Tech Services ensures the highest level of service. Throughout the process, QTS will develop, coordinate, communicate and drive all necessary deliverables and documentation according to customer expectations and the standards demanded by the medical device industry.
Contact us for more information regarding outsourced medical device assembly and packaging services.
Package Design Assistance
Package design considers design, distribution and market factors. Working with our customer, we define the needs and wants, and co-develop a package appropriate for distribution and effective in the use environments of the medical device.
Engineering Validations
To validate that the package integrity has been maintained throughout the package's processing, expected shelf-life and handling, we employ physical test methods that exceed our customers' quality requirements.
Label Development & Printing
At QTS, we take customer-supplied data to develop a database as well as design and print labels that communicate materials specifications, lot numbers, expiration dates, instructions, logos and any significant information the product requires, including barcodes. Our process ensures compliance to EN980 and AAMI label content guidelines, and we can help implement GS-1 and HIBC package barcodes that are FDA UDI compliant.
Critical Inspection Services
When it comes to critical inspection of medical devices, we understand the rigorous requirements involved. That's why we help ensure your product meets your critical requirements and acceptance criteria. Whether utilizing industry standards or creating custom inspection plans, engineers at QTS collaborate with you to develop the right inspection procedures for your medical devices and related components.
Cleaning & Passivation
Depending on the device, the material type, and the amount of impurities found on the device, we can provide a variety of effective, industry-regulated cleans required before the device enters a cleanroom.
ISO 13485 Medical Assembly & Packaging
We develop customer-specific assembly procedures to meet individual customer specifications for every project. Documented procedures and guidelines are executed by highly trained technicians on validated equipment, and our skilled technicians prepare assemblies with meticulous accuracy upheld by redundant verifications, and utilize specialized or customer-supplied equipment.
Medical Device Sterilization Contract Services
QTS assists customers with various medical device sterilization services including ETO, Gamma and Steam Sterilization. We create protocols, complete validations, coordinate lab testing, implement routine processing, as well as perform quarterly dose audits and annual revalidations, and have a sterilization specialist on staff to provide expert advice and guidance.
Supply Chain Management
QTS can find the best medical packaging materials for every project. Once the materials are identified they are sourced through our well-established network of industry-recognized and approved suppliers. Our minimum and maximum inventory level capacity can help lower costs and reduce lead times. We can also develop inspection approaches to ensure defects are caught early to maintain quality throughout the entire process. Pick, Pack & Ship (PPS) distribution services provide inventory management, shipment and distribution of your medical device to your customers or distributors, removing an extra step in the process and getting your devices delivered faster and more efficiently.
