Integrating compliance at the early stages of your process minimises cost and impact. It can often make design decisions easier and result in a better product and a smoother running project.
When should compliance start? In theory, we could start on day one when writing the requirements. This could be as simple as picking the relevant standards and understanding if there are any specific ones that apply to your type of device. Moving forward, it is useful (but not essential) to have an overview of the requirements in the standards during the proof-of-concept stage. This is purely to avoid missing an essential feature or waste time on a solution that can never be realised.
After the Alpha testing, when the Beta design starts, we should be designing for compliance. This means that you need to have a thorough understanding of the requirements in the applicable standards and that you need to be able to implement them. If the project needs notified body testing, now is a good time to involve them – from discussing your approach at the start, to having a design review before you commit to prototypes. You can then use this information to make informed decisions about everything from the PCB layout and component selection to the mechanical design, materials, labelling and manual.
At the final stages of Beta testing, when optimisation and any required changes are finished, we recommend a final design review. This would involve submitting a Beta prototype and the design files for assessment and possibly a small selection of high-risk “look-see” tests (for example EMC).
Having addressed any outstanding issues, you will need to submit your preproduction prototypes for full testing, or specific tests if self-certifying. Integrating type testing early into the process should present a substantially lower risk.
If you do not have the experience or know-how to manage this yourself, why not contact Blue Lightning Solutions and ask about our Product Design & Development? A service that helps you transfer all aspects of your concept from a prototype to a production-ready product.