Regulatory, Test House, Documentation ?
Whatever the problem, don't feel like this ...
We know there are times when a solid prototype design has been produced through experience, hard work and good engineering without all of the design infrastructure in place. A good working prototype, but no paperwork or test evidence to back it up. There is almost never time to go back and document the design, picking out the test cases that need to be pulled forward for verification and validation. We are experienced in taking these designs and wrapping them around design structure. By capturing the critical requirements and test specifications we will save you immeasurable time and pain down the line. We will produce the design documentation or provide you with a full gap analysis against good engineering practice and/or appropriate standards.
Too many times projects have to back-fill work right at the end when the pressure is most fierce. We can be a strong and supportive partner in helping you get the work done, even down to writing missing documents and checking that everything you've got is coherent and self-consistent.We have the attention to detail that you need
We can support you in ensuring your product fulfils the regulatory requirements for medical devices. We're experienced in understanding and interpreting the relevant standards - whether that's IEC 60601-1, IEC 60068-2-6, IEC 62304, etc. Performing a gap analysis against PEMS, electrical safety, radiation safety or risk analysis could be a time-saving (and money saving) exercise prior to sending the product to the test house. Even as early as the product concept stage, an understanding and simple capture of the regulatory requirements is crucial. The mechanical engineers need to know why they can’t use stainless steel screws in the device and the electronics engineers need to know where to place components such that the high voltages are as far as possible from the patient.
UDA will work with you to build these into product requirements or to check compliance with a gap analysis, creating a compliance checklist for future projects.
Those boxes need to be ticked and we are serious - if you have submitted a product to the Test House recently, you will be aware of their checklists. Complete Technical File with risk analysis, failure mode analysis, safety analysis, conformity, regulatory compliance.....testing, testing and more testing (— how about automated testing of your device? —) We're a fresh pair of eyes to help you check that you have covered all the angles before the product goes out the door for evaluation. We are your independent, external, technical reviewer helping you mitigate the risk of sending a device for testing and evaluation with a weak design history. It’s that last project risk on the plan that has no contingency because that was all used up in the design process.
Document control, document structure, documentation management, configuration management, traceability, full design history, change management, change control - all necessary chores, all (if we're honest) a bit tedious and easy to lose focus on. Engineers don’t like to spend the time and effort on these non-technical details. They want to do their best feat of engineering and move onto the next interesting thing. Worse than that, there are interfaces between the disciplines: hardware/firmware, software/firmware, communication/processing, hardware/thermal, mechanical/thermal, glass/metal, metal/polymer, etc. Here bucks are passed and responsibility hard to pin down. This is where we, as reviewers, see some of the biggest design documentation gaps. We’ll help you fill in the blanks and pull it all together.