YOOme @MEDICA and COMPAMED 2023
The whole world of medicine: Live in Düsseldorf from 13 to 16 November It won’t be long till the international medtech experts meet at MEDICA and COMPAMED 2023 in Düsseldorf. This year, for the first time at the world forum for medicine: YOOme – the largest group of companies for the engineering of your medical products in Europe. Together with the teams from BAYOOCARE, Mechatronic, Puls Produktdesign and UID, we as YOOme provide all the services of the entire medical device journey for you. Would you like to talk to us about your product idea? You will [...]
Data Protection Policy
Data Protection Policy 1. name and contact details of the controller This data protection information applies to data processing by: Responsible person: BAYOOMED GMBH Europaplatz 5 64293 Darmstadt Tel: 06151 / 8618-0 Fax: 06151 / 8618-150 E-Mail: info@bayoomed.com Homepage: https://www.bayoomed.com/ 2. name and address of the data protection officer There is currently no obligation for the controller to appoint a data protection officer. Any data subject can contact our controller/person etc. directly at any time with any questions or suggestions regarding data protection using the contact details provided above. 3. definitions The data protection notice of BAYOOMED GMBH is based [...]
Imprint
Imprint Publisher: BAYOOMED GmbHEuropaplatz 5D-64293 Darmstadt Phone: +49(0) 61 51 – 86 18 – 0Telefax: +49(0) 61 51 – 86 18 – 150info@bayoomed.com Commercial Register Darmstadt Nr. HRB 103073 USt-ID: DE351624359 CEO: Dipl.-Inf. Miriam Schulze Dipl.-Wirtsch.-Ing. Frank Manger Dipl.-Wirtsch.-Ing. Stefan Becher Legal matters and data protection These Internet pages are intended to provide general information about BAYOOMED GmbH, our services and products. We endeavor to provide you with up-to-date information. However, we do not guarantee the accuracy and completeness of the information. Furthermore, we accept no liability for any kind of damage resulting from the use of the information [...]
YOOme
YOOme - your medical experts We are convinced that only outstanding medical products can achieve outstanding success in marketing and application. With the YOOme brand, we are at your side as a partner to develop first-class medical devices with you and introduce them to the market quickly and safely. From the initial idea to smooth certification, reliable production and post-market surveillance, we are at your side: one schedule, one contact, one goal. YOOme - We are a team of five subsidiaries of the BAYOONET Group: Development and manufacturing Medical software [...]
This is how we work
This is how we work Requirement management Software development in the field of medical technology products and digital solutions in the healthcare sector ranges between your individual requirements and strict legal requirements. Agile requirement management is needed to meet both conditions. Our requirements engineers are faced with the constant challenge of keeping an eye on the changing, specific requirements of our customers and complying with the IEC 62304 standard at the same time. This is because the complete documentation of software requirements in accordance with IEC 62304 and QSR (in the USA) is also required [...]
Certifications
Certifications What we are particularly proud of? Our sustainable business solutions and the fact that we achieve the best results for you with our established processes. And this is also confirmed by TÜV Hessen. This is becauseour quality management processes are ISO 13485 certified and MDSAP-compliant. This quality policy obliges us to develop secure, reliable and equally innovative software solutions. At the same time, we do not lose sight of the user experience. Our processes We work with state-of-the-art technology and at the same time always keep an eye on the [...]
Development
Our expertise for your success Medtech, pharma or life science: discover the future of medical technology. We create digital transformations and realize your medical software project. What we can develop for you Mobile Medical Apps Learn more DiGA Learn more Companion Apps Learn more Cloud-based solutions Learn more DTx Learn more Embedded Software Learn more Your journey with us We support you step by step on your journey to the perfect solution for your [...]
Post-Market Surveillance
Post-market surveillance: What happens after the product is placed on the market? Post-Market Surveillance (PMS), i.e. the monitoring and review of approved medical devices, refers to the process after they have been placed on the market. The aim of this structured process is to identify possible corrective measures for your medical device. Here it is crucial to classify market behavior correctly. This is the focus of post-market surveillance identify the risks determine the effectiveness compared to other products be able to initiate significant measures quickly identify existing safety issues update [...]
Risk Management
Risk management for medical devices and in-vitro diagnostics Medizinprodukte, die im oder am Menschen angewendet werden, bergen ein gewisses Maß an Risiko. Es besteht ein besonders hochgradiges Schutzniveau, weshalb das verbleibende Restrisiko mit dem Nutzen des Produkts abzuwägen ist. In deutschem, europäischem und amerikanischem Recht für Medizinprodukte wird daher übereinstimmend ein Risikomanagement für Medizinprodukte und In-Vitro-Diagnostika gefordert. 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 describes the risk management process for medical [...]
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 [...]