At B&W Tek, we are experts at the generation, manipulation and delivery of light for medical applications. We deliver complete, high performance solutions, to which power, wavelength, beam shaping, delivery, stability, and thermal management are key on a technical level. More importantly, we put a great emphasis in design and build on safety, reliability, and controlling risk, which is the key difference between having a functional device and having one that can ultimately be implemented and used as a medical system.
With the adoption of IEC/EN 60601-1 3rd edition, the “one wavelength for all” era ended. It is no longer possible to select a laser product for an application without careful and thoughtful consideration of fit for intended use and effective and proper control of risk. The laser system is now a component of the overall medical device and cannot be considered as a device in and unto itself.
U.S. Food and Drug Administration (FDA) and International Standards (IEC/EN) require use-related risks to be identified, mitigated, and validated as part of a formal risk analysis process. Even if hardware is identical, it may need to work very differently, as the indication being treated drives the critical analysis of performance, usability, risk, and system safety. Regulatory bodies look for documented procedures that address all these concerns and more during the development process.
Questions that we ask the customer include:
What is the device used for, and what is its overall role in treatment?
Where will the device be used and how do you ensure that training is effective?
Does the design address the needs and requirements of the intended users?
What is the user interface, and is it clear, concise and unambiguous?
What are possible problems that could arise?
What are potential problems that could occur if the device is used outside of normal usage parameters?
Have the hazards and risks associated with the use of the device been carefully analyzed?
Can all of your design processes be summarized to address this list of questions and more?
Can this summary support all of these statements, be submitted to a regulatory body or 3rd party, and withstand examination?
With a team that understands all these requirements and how to work together with our customers, we are able to deliver an effective solution that addresses the needs and fulfills the requirements. Our expertise in the generation and manipulation of light is critical to the process as we communicate with users, prove the design is effective, and minimize hazard in pursuit of a product.
Click here to see how our OEM process works from start to finish.
Do you need an effective and capable partner to work with you on your application in light? Fill out the form here to consult with an expert today!