VERIFICATION & VALIDATION
The testing plan for this activity is directly related through the risk management plan to the user needs. Our testing methods vary depending on the project and usually accommodate multiple user needs and risk items.
In house we have the expertise to define, set-up, test and evaluate our required verification tests in accordance with ISO 13485.
The first phase of any product development project is generally the feasibility phase. This phase involves assessing the commercial potential of a new project prior to pursuing its development. The phase specifically answers the question;
“should we proceed with the proposed project idea?”.
Activities within the phase answer this question from various different approaches. These activities include; market analysis and validation, profile of competitor landscape, analyse the patent landscape, develop IP strategy, investigate potential routes to market, regulatory assessment, reimbursement strategy, technical proof of concept.
The outcome of these activities leads to a go no-go decision on the viability of the proposed project.
When the feasibility study has been completed and if the decision has been taken to progress the project, a planning stage is started where the foundation of the project is cultivated.
At this stage the projects phases and activities are outlined along with the responsibilities and authorities. Risk management activities are started at this stage as well as manufacturing and supplier identification, commercialisation experts and regulatory requirements.
The development stage runs through an iterative process which is first realised in the feasibility and planning stages combined. Concepts are prototyped and tested. Design reviews bring together the combined expertise of MEDIC to critique the design and focus the most desirable attributes from each design.
MEDIC utilises 3D modelling software and FEA mathematical modelling software to allow quick precise and informed design solutions. Our model making and prototyping lab allows us to explore many concepts giving us clear insight . There are many in-house skills available to us: Ergonomics, style, usability, rapid moulding. All lead to an upfront understanding of the design problem.
Commercialisation is a main activity that is present in all stages of the project.
Every step of the way MEDIC refines its plan for commercialisation responding to more defined user needs, regulatory feedback and product placement within the customer environment.
MEDIC Design Process:
The process which MEDIC employs conforms to the ISO 13485 industry standard for design controls. Our on-site capabilities allow us to perform all stages of our design process in-house, with subject-matter-experts.
Our engineering expertise gives us the ability to define a design problem and take scientific and practical approaches towards solving the problem.
Prototyping is one of the key design tools that allow us to verify our approaches and confirm our solutions. We have a steadily growing number of prototyping techniques from which to draw on including 3D printing.
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