Harland Medical Systems Certification Services
Why use HMS Certification Services?
- Harland’s certification service provides a standardized methodology to optimize the validation lifecycle to cover only the required steps and checks.
- Harland’s equipment certification service provides documented independent verification and validation of your system’s performance.
- Purchasing equipment for validating products can be a costly venture. Harland’s certification service can offset this cost without jeopardizing the end results. Experienced and qualified staff for managing your validation process is also expensive.
- Harland’s certification service performs routine checks to further improve your process and prevent lapses in quality.
- Just like any other industry, there are a range of certifications and compliance norms for service providers, so you can be sure of what to expect.
- When combined with an annual service maintenance program, recertification is included with parts and labor coverage, providing a complete system protection program and greatly reducing any risk to your operation and quality system.
Harland offers certification services for both its FTS Friction Test System and their automated coating equipment:
The FTS Friction Test System is a compact, versatile instrument specifically designed for measuring lubricious coating performance on medical devices such as catheters, guide wires, pacing leads, and similar products. The FTS 6000 measures both surface friction and coating durability by drawing the test sample between two silicone rubber pads clamped at a programmable force.
To ensure the continued fitness for the purpose of your FTS metrology system, Harland offers annual recertification and recalibration services by trained and certified personnel. ISO13485 (section 7.6) and ISO9001 (section 18.104.22.168) specify that to ensure valid results, measuring equipment shall
- be calibrated or verified, or both, at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards
- be adjusted or re-adjusted as necessary: such adjustments or re-adjustments shall be recorded;
- have identification in order to determine its calibration status;
- be safeguarded from adjustments that would invalidate the measurement result;
- be protected from damage and deterioration during handling, maintenance and storage.
Request for Machine Service:
- If your situation is urgent, please call 952-941-0475.
- If you have a service contract for this machine and want expedited service, please submit your request here.
- If you do not have a service contract, please complete the form below.
- If you would like to order a service contract for your machine, please complete the form below with your request.
Supplies and Spare Parts:
Coating machine supplies and spare parts.
Friction test equipment supplies and spare parts.