Usability for standard-compliant medical devices
The conflicting priorities of safety and aesthetics are a constant issue in the development of medical devices – we support you systematically on your way to a safe medical device.User errors on medical devices are among the most common causes of accidents in the healthcare sector. So how can they be minimized or avoided altogether? UID's Medical & Pharmaceuticals division provides user-centered design and software engineering from the first product sketch to the approval in accordance with DIN EN 60601-1-6 and EN 62366. Secure the market position of your medical devices by providing users with a safe and aesthetic operational concept and employing current trends such as medical apps or home care products.
Our team of experienced experts supports you during the development and approval process of your medical device – from the initial idea to the validation and the submission of the usability engineering file to the certifying body. We combine the strict regulatory requirements for medical devices with an exceptional design quality.
Therefore we perfectly match the user interface of your medical device with the multifaceted operating scenarios and users – from medical diagnoses carried out by doctors or clinical staff to therapeutic measures provided by non-professionals, such as care-giving family members, or the support of vital functions.
Our services at a glance
- medical device design: concept and design of intuitive, safe and standard-compliant medical devices in the fields of diagnostic software, life-support systems, laboratory and hospital information management systems as well as software systems for pharmaceutical materials management
- international human factors engineering and UX research: analyzing the requirements of users and usage contexts
- regulatory compliance: support in usability engineering and creation of the usability engineering file in accordance with DIN EN 60601-1-6 and DIN EN 62366
- international evaluation of medical devices: verification and validation of the suitability for purpose with representative users and realistic test parameters in our own test studio
- implementation of your user interface in many programming languages
- profound medical knowledge and almost two decades of experience in usability engineering for medical devices
- understanding and meeting the specific requirements for the development of medical devices and relevant standards such as DIN EN 60601-1-6 and DIN EN 62366
- employing current trends in medical engineering such as medical apps, connected life, home care & medical wellness devices or BYOD for medical devices
- responsible and ethical way of working (data protection and protection of test participants, self-commitment and standard operating procedures)
- cooperation with ethical review boards such as the Bavarian medical association (Bayerische Ärztekammer) or various institutions in the US
- certified quality management in accordance with ISO 9001
- successful audits by three global customers from the medical sector