Medical Device Life-Cycle & Validation Services

• Accelerated Life Testing (ALT) or Accelerated Lifecycle Fatigue & Environmental Testing
• ISO 17025 and GLP accredited for customer supplied or custom parameters
• Accelerate your project timeline: 100 cycles in 3-4 weeks typical
• Extensive photographic documentation (T=0, T=1 and T=Final) records
• Accommodate all surgical device types, quantities, materials, or any reusable device
• Test protocol consulting with current best practices
• Wide range of in house (US and EU) detergent chemistries and process parameters
• Includes full ISO certification showing all steps and parameters and photos

• Comprehensive functional testing with full device actuation or assembly
• Accommodate IVD or handheld devices with disinfectant exposure through lifecycle
• Device soiling using approved methods; whole, DBLSO or other blood soil
• Interim evaluation (T=0 and T=interim) of your device to help you determine if design changes are needed before testing continues
• Full technical memorandum with methods, materials and photos – additional cost
• Expedited studies – addition cost

• Study items are unpacked and an electronic router of all job steps is created in alignment with your IFU and/or testing protocol.
• The test devices are inventoried and photo-documented with specific attention to any regions of interest identified by our clients.
• Time zero (T=0) pictures are always captured prior to the start of testing to document the initial condition of the devices.

For complex or multi-component instrumentation, functionality checks can be performed and assessed at interim points throughout testing when requested by the client. Functional cycles simulate the use of the instrument in the field. Assessments could include any or all of the following activities:

• • Soiling the device with bovine blood or other representative soil
  • Actuation of moving parts, assembly of mating components, locking/unlocking mechanisms
  • QR code scanning, powering the device on/off, leak checks, etc.
  • Mechanical testing such as compression, tension, torsion, or impact testing

• An ultrasonic bath uses high-frequency sound waves to agitate the included detergent. We use the same baths to replicate these conditions for your device.
• Devices are cleaned manually in an enzymatic or alkaline detergent bath.
• Elevated temperatures of 40º – 65ºC are typically used in clinical settings.

• The detergents and high temperature conditions in the automatic washers used in hospitals create a harsh environment that your device will experience in the field.
• We utilize the same washer/disinfector equipment found in hospitals and surgery centers to replicate detergent impingements and high-temperature disinfection conditions that the device will see in real-world use.  We follow your Instructions for Use (IFU) to set the methods and parameters for this process.

In a hospital, autoclaves provide the sterilization conditions for devices between uses. We utilize autoclaves to replicate those conditions and determine how they can affect your device’s functionality and durability.

• A pre-vacuum autoclave unit is one that evacuates the chamber and pulses a steam charge several times before the timed steam charge is initiated. It then dries the devices under a high (greater than 10 inHg) vacuum.
• Most steam charge cycles are 4-18 minutes long at temperatures above 132ºC and below 137ºC..

We document all changes to the device throughout the testing with a comprehensive record of photographs at prescribed milestones, cycles completed, and when changes are first observed.

Your completed study will include a copy of this photo record along with a full certification of what each device was exposed to during this process, including time, temperatures, chemicals, and cycle counts.

Additionally, BoneSim can provide a full technical report for submission to governing bodies.

The full technical report will include:

• Executive Summary
• Background Materials
• Methods
• Results and Discussion
• Conclusion
• Relevant Photographs and References