Optimation's knowledge and experience with test systems for medical devices makes us an asset to your team. Our project methodology and processes are ISO 13485 registered. Our skilled trades personnel are journeymen level with the expertise and experience to fabricate and assemble a test system to meet your requirements.
We can provide engineering and skilled trade services for medical device test systems at any point of your project life cycle.
- Design a test system concept or assist in the determination of your test system requirements
- Integrate and/or update an existing test system
- Provide validation assistance on an installed test system
We are flexible enough to meet your system delivery and custom installation needs for your test system. Upon system delivery, our engineers can provide onsite training to your system operators along with training documentation (i.e. operator manuals).
From concept to completion, Optimation offers engineering and skilled trade services that provide you with a test system for your medical device.
Experienced Medical Device Test System Project Managers
Throughout your test systems project life cycle, we are a part of your project team. All our projects have a designated project manager who works closely with your team and our internal project team to execute each phase of the project life cycle. Our project managers are trained in our ISO 13485 registered processes.
Test System Retrofit Expertise
Optimation can retrofit your existing integrated or standalone/single test cell with new or improved features, components and software upgrades creating a new variant of your existing test system. Cost effectiveness is one of our top priorities. We pride ourselves in providing a solution that has a significant return on investment for our clients.
Our test system engineer's knowledge and experience allows flexible software development. If there is an existing test system that requires an upgrade, our software engineers are savvy and flexible enough to work with or rewrite your existing or inherited code.
Extensive Experience in Test System Design
Optimation will provide you with the knowledge and expertise to design your test system. Our engineers have extensive test system design experience and have worked with various software applications and off-the-shelf hardware. We can:
- Aid in conceptualization and finalization of your test system requirements
- Design and develop an integrated or standalone/single test cell
- Design and develop test documentation to verify the functionality of the integrated or standalone test cell
Typical design inputs and outputs for medical device test systems are shown below.
We have been highly involved in Phase 1 (Project Initiation), Phase 2 (Risk Management), Phase 4 (Verification) and Phase 5 (Validation). Our involvement during these phases provides Optimation with a competitive advantage.
Extensive Knowledge in Test System Validation
Optimation has proven processes and documentation for test system validation. We believe traceability is key to the qualification of an installed and operating test system. Why use our services to assist in test system validation?
- Our engineers understand the importance of documentation traceability relating to test system validation
- Our validation templates and processes are GAMP compliant and ISO 13485 registered.
- We have templates available for use, and we can also work with your preferred documentation. Validation templates can include:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation Summary Report (VSR)
Regardless of whether or not Optimation assisted in the design and installation of your test system we can validate it. Often times our validation services have been a gateway to concept to completion projects with our clients.
Risk Management Assistance
The scope of our risk management is related to our test system deliverable. We assist you with the risk management of our deliverable based on your identified risk by:
- Designing risk mitigation into our design, in accordance with our ISO 13485 registered risk management processes
- Managing your identified risks throughout the project life cycle