"Do you want to quickly and systematically identify requirements and concise and compliant usability files?"
How do you know the requirements of your customers and users of your medical device? Just ask? Perform a workshop? No! Henry Ford already knew the answer to that: "If I had asked my customers what they wanted, they would have said a faster horse."
The identification of requirements is not a matter of direct enquiries, of chance or of personal preferences. You will learn in the seminar:
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As a product manager you will learn to collect comprehensive, precise and stable stakeholder requirements. You will learn to define the roles product management, usability engineer, requirements engineer and developer. A precise definition of tasks, competencies and responsibilities will help you to avoid friction losses.
As a manufacturer you can avoid the perpetual re-specifying and touching up of your products. This will save you valuable time and unnecessary costs.
In this seminar you will learn that requirements engineering is a systematical innovation process that will lead to products that your users really need and appreciate. Your new products, that actually deserve the attribute "innovative", give you the opportunity to achieve market leadership.
You will avoid problems in the audit specifically regarding ISO 14971, IEC 62366 or IEC 60601-1-6 and FDA requirements. You will learn to verify and validate the usability of your products and to compile a compliant usability / human factors engineering file.
All regulations require that medical device manufacturers have to proof a systematically training and education of personell - also with respect to usability / human factors engineering.
Any questions or comments? Do you prefer a seminar tailored for your specific needs? Contact us now. We look forward to hearing from you!
Contact us for more information about the costs, next dates and to register.