Risk Management
Risk management for medical devices and in-vitro diagnostics Medical products used in or on humans carry a certain degree of risk. There is a particularly high level of protection, which is why the remaining residual risk must be weighed against the benefits of the product. German, European and American law for medical devices therefore consistently require risk management for medical devices and in-vitro diagnostics. ISO 14971 in risk management ISO 14971 is assigned to the medical technology sector and is entitled “Medical devices – Application of risk management to medical devices”. It [...]
Clinical evaluation
Clinical evaluation: from initial planning to post-market clinical follow-up According to Regulation 2017 / 745 (MDR), clinical evaluation is an essential part of the conformity assessment procedure for manufacturers of medical devices of all risk classes for successful market access. The clinical evaluation serves as systematic proof that the medical device fulfils basic safety and performance requirements and that undesirable side effects are taken into account and excluded. Thus, it serves as evidence of the justifiability of the benefit-risk ratio. Furthermore, the continuous and regular updating of the clinical evaluation after the medical device has been placed [...]
ISMS
Your path to an information security management system (ISMS) in accordance with ISO 27001 Your path to an information security management system (ISMS) in accordance with ISO 27001 Do you want to improve the security of your organization's assets and information? Or do you simply need ISO 27001 certification for your projects, e.g. for the launch of your DiGA? Then you've come to the right place. As experts in digital health, we can offer you services in the field of information security management systems (ISMS) based on ISO 27001, as this is exactly what we have experience in. [...]
Companion Apps
Intelligent assistants: this is what companion apps offer They are linked to drug treatments and help patients to better understand and manage their health - medical companion apps. Through innovative technologies, comp a n i o n apps provide tailored information, reminders and support to ensure patients take their medication correctly and achieve their health goals. Why are companion apps that important in the pharmaceutical industry? Personalized support Companion apps offer personalized advice and reminders tailored to individual health conditions and treatment plans. This customized support promotes adherence and [...]
DTx
Why is DTx important? DTx refers to evidence-based therapeutic measures that are controlled by software (e.g. apps) to treat medical conditions. These digital solutions combine medical knowledge with cutting-edge technology to provide personalized and effective treatments that empower patients to take control of their condition. Mobile healthcare DTx ensures that healthcare is not dependent on time and location. Patients can access these therapies from home. This ensures continuous treatment and support. Personalized therapy Every person is unique, and DTx solutions recognize this diversity. They offer [...]
AI
Künstliche Intelligenz für Medizinprodukte With AI applications and learning algorithms, health data can be used for diagnostics, therapy or even prevention in previously unknown quality and quantity. Artificial intelligence is used primarily in the fields of neurology, cardiology, oncology and ophthalmology. But examples of successful integration of AI in medicine can be found in various fields. Artificial intelligence in the app BAYOOMED has already successfully launched an AI-based app on the market with the MyIUS app. MyIUS helps users of an intrauterine device (IUS), among other things, to predict the bleeding profile. [...]
Embedded Software
Software as a medical device: What is important for embedded software Embedded systems vary widely, from small systems with tiny microcontrollers and specialized runtime environments to large systems with full system-on-a-chip technologies and embedded Linux. This diversity requires a variety of tools and software stacks, each of which has its own special features What does embedded software consist of? Embedded-Systeme bestehen oft nicht nur aus einem Mikroprozessor, sondern aus einer Reihe von Prozessoren mit unterschiedlichen Aufgaben: Herstellung von Verbindungen zu externen Systemen, Bereitstellung von Benutzerschnittstellen und Ansteuerung von Sensoren oder Aktoren.Diese Prozessoren müssen miteinander [...]
Web and cloud-based solutions
Optimized collaboration through web and cloud-based solutions The use of web and cloud-based solutions significantly improves collaboration in the healthcare sector. Patients, caregivers, healthcare professionals and administration can access relevant patient data in real time, regardless of their location. This promotes efficient communication and enables faster diagnosis and more precise treatment planning. What advantages do web- and cloud-based solutions offer you? Integration Web and cloud-based applications enable the integration of innovative technologies such as artificial intelligence (AI) and machine learning. These technologies help to analyze medical data and identify patterns. This enables more precise diagnoses [...]
BAYOOMED @MedConf
Meet us at MedConf 2023! At MedConf 2023, from May 23 to 25 in Munich, everything will once again revolve around the development of software and medical devices in the medtech sector. The conference with accompanying exhibition is considered the most established and important networking platform in medical technology – which is why we will be there again live on site. During the three days of the conference you can meet Sebastian Wittor and Florian Mayer from BAYOOMED. What? When? How? Where? Find out here. The main topics of this year’s MedConf include software development and quality assurance as well [...]
Team
This is us Our aim is to support you personally with your project right from the start and advise you on all questions relating to your medical software or medical app. That's why our qualified co-thinkers are passionate about developing your software solution from our five locations in Germany. And it's just as simple as it sounds: you describe your vision to us and we provide you with the matching medical software. We check exactly which technology suits your project. With our expertise and many years of experience, we will guide you to your goal [...]