November 3, 2020
Simplifying project preparation
This is our second installment of “Are You Ready For Your Testing and Certification Process?” where we are discussing things that can be done to make your testing and certification process easier.
Last month, we covered planning for compliance and as mentioned, the first step in a successful project is getting the correct items ready for submission. Without the correct items, the project scope, testing and evaluation can be delayed. This month, we will take a look at the five key items that you can start preparing now to get your project started on the right path.
Intended use of the product
This single item is key for determining the standard(s) to be used for the project. While devices can have similar features, the key in determining the applicability of the particular/collateral standard(s) comes down to the intended use. As the manufacturer, we need you to define the intended use of the device. This definition will lay the groundwork for the project. Note: the device may have more than one intended use and if so, we will need to know this, eg. : a device could be for use in a household, ambulance or hospital.
Multiple units for the evaluation and/or additional parts
While an investigation can be completed with one sample, it may cause delays and testing issues. For example, when a project begins, we will start with a construction review that will require the unit be partially disassembled. With only one sample, that unit will end up in the laboratory or testing after our team reassembles the unit. If the test program involves any IPXX rating (ingress protection, such as water ingress), this can have an impact on the testing outcome. With multiple samples, we can ensure samples that have not been disassembled by our team are used for sensitive tests such as IPXX.
A list of all model numbers being submitted with information on model variations
We will need details on all of the models you would like to have evaluated. This is critical to setting up the project scope. We will need to know specific details on the differences between the models being submitted. One of the best ways to communicate this information is in a table outlining the differences such as electrical components, enclosure size/materials, ratings, etc. This will allow our teams to better understand and determine the representative model(s) that will need to be evaluated.
Instruction manual (aka instructions for use)
For many manufacturers, this may be one of the last items to be completed. However, a delay in providing the manual can cause significant delays to the project. The standard(s) will typically have specific items required to be included in the instruction manual. If the manual is not finalized, a working draft should at least be provided early to ensure a clear understanding of the functions, intended use and basic ratings. If provided later in the project, it may lead to the need for retesting and/or redesign.
Risk management (RM) file for medical products
For medical product evaluations, receiving the RM file early also minimizes the risk of issues later in the project. Specifically, this will allow us to:
- Identify the performance of clinical functions other than those related to basic safety. This is necessary to achieve the intended use, or safety could be impacted.
- Specify performance limits between fully functional and total loss of the identified performance in both normal and single fault conditions
- Evaluate the risk from loss or degradation of the identified performance beyond the specified limits where the resulting risk is unacceptable, the identified performance is essential performance
- Implement risk control measures to reduce these risks to an acceptable level for both normal and single fault conditions
- Specify methods for the verification of the risk control measures effectiveness
- Assess and determine which risk control measures need verification of effectiveness
In many cases, items such as additional samples and instruction for use may not be ready at the start of the project. When that is the case, this needs to be identified to start the discussion of other options and what risks that brings to the investigation. We are always available to discuss how a change and/or lack of available items will impact the project.
Now that you understand the key items needed to get a project started successfully, we want you to understand what to expect during the actual investigation. We will examine the project phases in our future newsletters.