Methods for Coating Medical Devices
Details, Parameters, Process, and Validation Steps required for Coating Medical Devices
Methods represents the second “M” in The 4M Framework. Methods, are the detailed description of every critical detail, parameter, process, and validation step required to consistently deploy an advanced surface on your healthcare product. Methods are perfected through our Method Development Services that matches the pace of your product development cycle until the final product is ready for launch.
As your product progresses through each step, the Methods template is refined while monitoring and integrating all your technical, production, and economic requirements through project completion.
Harland’s detailed and comprehensive Methods provide:
- Functional and technical requirements
- Manufacturing processes
- Set up parameters
- Machine protocols
- Work instructions
- Validation test procedures
Methods created by Harland are designed to accurately and consistently produce a quality surface enhancement result that meets the critical specifications of your product. Additionally, validation steps are included to measure and monitor key metrics that ensure the specifications are achieved and maintained – time after time!