• You are here:
• Home >
• Quality >
• Design Process

Design Process

Our design and manufacturing processes are approved and audited to ISO9001 and we have achieved Scope extension to this quality standard to enable us to specifically design software. This process is audited by Tick-IT inspectors. We have a very broad experience of various quality standards and processes required for different marketplaces, including supporting clients in achieving FDA approval.

Our unique 5 stage development process means that we can develop cost-effective turnkey systems through to individual component designs – from initial feasibility studies, to full production manufacture.

Stage 1 - Feasibility study

The MLE team will investigate the feasibility of your project to establish if key parameters can be met. The result of this stage typically identifies risk areas, approximate production costs and timescales. During this stage we may conduct CAD studies of strategic problems.

Initial Design Review - IDR

This establishes the key design goals such as design costs, functionality, reliability, technologies. It identifies applicable MLE modules, the scope of the client application software and hardware and the mechanical layout and documentation needs in light of the identified risk areas.

Stage 2 - Bench Study

We develop and build a prototype which will prove operation and functionality of specific areas of your product. These will be areas identified as high risk during the previous study and will typically consist of PCBs rapidly produced on our in-house routing machine. These PCBs may have hand wires and additional components fitted as separate modules. The mechanical design may show the form of the final unit but will not be representative of the final layout. The benefit to you of this Stage is that it proves new concepts and the electrical principles, thus reducing any high-risk aspects of the product development early on.

Stage 3 - Engineering Prototype

During this Stage we develop and build a ‘first off’ functional prototype which has most of the functionality of your final product and is basically the correct shape of the final unit. This unit may be manufactured using the in-house routing machine to provide fast turn round. At this stage you will be able to ‘see’ your product for the first time as a real shape and with operation close to the finished version. A document package is started for purchasing, manufacture and testing. It is normal to have several iterations of development and review during this stage as hands on use of the equipment, development constraints, new ideas and client feedback, usually identifies areas that allow performance, cost, size etc. improvements to be made.

Preliminary Design Review - PDR

This evaluates the first off engineering prototypes and ensures, given the present level of understanding, that the final prototype is right first time. Typical issues under review include technical specification, quality requirements, test results, drawing pack / documentation status, final test requirements, risk analysis and unit cost analysis.

Stage 4 - Representative Prototype Unit

The object of this Stage is to produce a first build or final prototype unit which will be fully functioning in all details of the specification. Any modifications identified during Stage 3 will be incorporated into the project. The blank PCBs will be manufactured by one of our recommended suppliers and our engineers will assemble the unit. The boards will be tested and fitted to mechanical assemblies. Final design verification takes place with testing against specification. The outcome of this Stage is a fully functional prototype and an evolving drawing package. It may be possible to perform some initial pre-compliance EMC testing on this unit.

Critical Design Review - CDR

The CDR revisits the specification and determines through verification that the final prototype is both complete and correct against the original requirements. The review also considers aspects such as Value Engineering, DFM, test specifications, test rigs, documentation packs, training, risk analysis and suppliers prior to the pre-production.

Stage 5 - Pre-Production Pilot Units

The drawing package that has been produced during Stage 4 will be placed with our manufacturing facility for a build run of possibly 5 or more pilot units depending on the scale of the project. Any unforeseen hitches or improvements in the production process can be identified during this Stage and are recorded using our engineering change control process.

This build and testing of the final units gives initial confidence in manufacturability and spread of tolerances. After updating the drawing package, the product is fully documented and performance verified.

Production Readiness Review - PRR

This review takes place prior to production release and typically considers tooling, health and safety, training, packing and labelling and costs analysis.

Production Release

Product is formally released to production.

Post Project Review

Plus/Delta on product and project.

EMC Pre-Compliance Testing

We are also able to provide pre-compliance testing to monitor EMC aspects of the project and to help reduce time spent at official calibrated ‘test’ houses. For investigative and pre-compliance testing we use a Sceptre spectrum analyser, bi-conical antenna and near field probe in a semi-screened room for emissions and a Mace transient generator and capacitive clamp for immunity. (This testing, whilst beneficial in evaluating and resolving some possible EMC issues, does not in any way guarantee passing formal EMC testing).

 

 

Print This Page