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BAYOONET AG
Europaplatz 5,
64293
Darmstadt
Germany
Germany
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Our range of products
Product categories
- 01 Imaging and diagnostics / medical equipment and devices
- 01.01 Diagnostics
- 01.01.12 Blood flow measurement equipment
Blood flow measurement equipment
- 03 Diagnostic tests
- 03.01 Clinical chemistry
- 03.01.01 Glucose testing
Glucose testing
- 06 IT systems and IT solutions
- 06.02 mHealth, mobile IT, wireless technologies (Bluetooth, WI-FI)
mHealth, mobile IT, wireless technologies (Bluetooth, WI-FI)
- 06 IT systems and IT solutions
- 06.03 Wearable technologies, smart textiles
Wearable technologies, smart textiles
- 06 IT systems and IT solutions
- 06.04 eHealth, telemedicine / telematics / telemetry
eHealth, telemedicine / telematics / telemetry
- 06 IT systems and IT solutions
- 06.05 Administrative information systems / software
- 06.05.01 Healthcare information systems / software (HIS)
Healthcare information systems / software (HIS)
- 06 IT systems and IT solutions
- 06.05 Administrative information systems / software
- 06.05.05 Cybersecurity, virus protection, intrusion protection, anti-spam and firewalls
Cybersecurity, virus protection, intrusion protection, anti-spam and firewalls
- 06 IT systems and IT solutions
- 06.05 Administrative information systems / software
- 06.05.06 Electronic medical record / electronic health record systems
Electronic medical record / electronic health record systems
- 06 IT systems and IT solutions
- 06.06 Medical information systems / software
- 06.06.01 Drug information systems
Drug information systems
- 06 IT systems and IT solutions
- 06.06 Medical information systems / software
- 06.06.02 Internet / web portals, healthcare portals
Internet / web portals, healthcare portals
- 06 IT systems and IT solutions
- 06.06 Medical information systems / software
- 06.06.04 Medical Apps and App Stores
Medical Apps and App Stores
- 07 Medical services and publications
- 07.01 Reports and analyses
Reports and analyses
- 07 Medical services and publications
- 07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
Our products
Product category: mHealth, mobile IT, wireless technologies (Bluetooth, WI-FI), eHealth, telemedicine / telematics / telemetry, Medical Apps and App Stores, Electronic medical record / electronic health record systems, Drug information systems
Mobile Medical Apps & DiGA
We develop Mobile Medical Apps & DiGA
Are you looking for support in developing your Mobile Medical App or DiGA? We are specialized in engineering of Mobile Medical Apps & DiGA for the healthcare industry. Our focus is the implementation of mobile applications for iPhone, iPad, Android Phones and Tablets - either native or as cross-platform application.
We have expertise in implementing mHealth and eHealth applications covering medical device classes I, IIa, IIb and III as well as software safety classes A, B and C of IEC 62304. Product engineers and innovators from the healthcare sector (health insurance companies, pharmaceutical and medical technology companies) count on our support throughout the entire product life cycle.
We support you in all areas:
Are you looking for support in developing your Mobile Medical App or DiGA? We are specialized in engineering of Mobile Medical Apps & DiGA for the healthcare industry. Our focus is the implementation of mobile applications for iPhone, iPad, Android Phones and Tablets - either native or as cross-platform application.
We have expertise in implementing mHealth and eHealth applications covering medical device classes I, IIa, IIb and III as well as software safety classes A, B and C of IEC 62304. Product engineers and innovators from the healthcare sector (health insurance companies, pharmaceutical and medical technology companies) count on our support throughout the entire product life cycle.
We support you in all areas:
- Requirements Management
- Software Engineering
- Risk Management
- Usability Engineering
- Testing, Verification & Validation
- Rollout & Ap Store Release
- CE marking / FDA approval / International Launching
- Support & Maintenance
- Post-Market Surveillance
Product category: Healthcare information systems / software (HIS), Internet / web portals, healthcare portals, Blood flow measurement equipment, Wearable technologies, smart textiles, Drug information systems, Glucose testing
Software development according to DIN EN 62304
Software development according to DIN EN 62304
At BAYOOMED we are specialized in developing medical apps, digital health applications (DiGA) and medical software. With over 10 years of project experience in the regulated medical and pharmaceutical environment, we are one of the most experienced medical software developers in Europe.
As the Medical Software Business Unit of BAYOONET AG, we focus on an agile way of working - more than 800 medical technology customers have already benefited from this.
We support you in all phases of the product life cycle, taking into account the regulations and requirements of your target market. Whether it is in the EU (MDR), the USA (FDA), Brazil (ANVISA) or other countries - we know the legal regulations and develop according to these requirements.
At BAYOOMED we are specialized in developing medical apps, digital health applications (DiGA) and medical software. With over 10 years of project experience in the regulated medical and pharmaceutical environment, we are one of the most experienced medical software developers in Europe.
As the Medical Software Business Unit of BAYOONET AG, we focus on an agile way of working - more than 800 medical technology customers have already benefited from this.
We support you in all phases of the product life cycle, taking into account the regulations and requirements of your target market. Whether it is in the EU (MDR), the USA (FDA), Brazil (ANVISA) or other countries - we know the legal regulations and develop according to these requirements.
Product category: Healthcare information systems / software (HIS), Reports and analyses, Certification and testing of medical devices, quality assurance, eHealth, telemedicine / telematics / telemetry
BAYOOSOFT Risk Manager - Convenient generation of technical documentation
Spend your time on content instead of form
Many standard processes related to the creation of technical documentation for medical devices, in-vitro diagnostics or actively implantable medical devices, as well as in the management of risk files, are carried out manually. This takes up unnecessary time and costs. At the same time, regulatory requirements for development and marketing have been steadily increasing in recent years.
To free yourself from this document jungle, the goal should be to break up monolithic documents into fine-granular data and let specialized software solutions do the work as far as possible.
As the world's leading software solution, the BAYOOSOFT Risk Manager supports you in the creation of technical documentation. In a clearly structured environment, all relevant information is recorded, centrally stored in an audit-proof manner and dynamically linked in a fine-granular manner. The information is made available to authorized employees throughout the company, a loss of knowledge due to employee turnover is avoided, particularly effective measures are identified and suggested, thus automatically avoiding redundant data storage. Reports are generated with the most current data at the push of a button.
In addition to the creation of the Risk Management File according to ISO 14971, the Usability Engineering File according to IEC EN 60601-1-6 / IEC 62366, the Conformity Report for Medical Electrical Devices according to IEC 60601-1 as well as the Essential Requirements according to MDR 2017/745 and IVDR 2017/746, BAYOOSOFT Risk Manager has a fully integrated Requirements Engineering module to support the traceability requirements of IEC 62304. The intuitive clinical evaluation approach systematically supports the process to collect and evaluate clinical data and confirm the performance and effectiveness of medical devices with a final overall analysis. In addition, it is possible to map the area of the medical IT network according to IEC 80001-1:2 via the BAYOOSOFT Risk Manager.
Your development and approval process is accelerated with BAYOOSOFT Risk Manager: You concentrate on the essentials and increase your productivity.
Many standard processes related to the creation of technical documentation for medical devices, in-vitro diagnostics or actively implantable medical devices, as well as in the management of risk files, are carried out manually. This takes up unnecessary time and costs. At the same time, regulatory requirements for development and marketing have been steadily increasing in recent years.
To free yourself from this document jungle, the goal should be to break up monolithic documents into fine-granular data and let specialized software solutions do the work as far as possible.
As the world's leading software solution, the BAYOOSOFT Risk Manager supports you in the creation of technical documentation. In a clearly structured environment, all relevant information is recorded, centrally stored in an audit-proof manner and dynamically linked in a fine-granular manner. The information is made available to authorized employees throughout the company, a loss of knowledge due to employee turnover is avoided, particularly effective measures are identified and suggested, thus automatically avoiding redundant data storage. Reports are generated with the most current data at the push of a button.
In addition to the creation of the Risk Management File according to ISO 14971, the Usability Engineering File according to IEC EN 60601-1-6 / IEC 62366, the Conformity Report for Medical Electrical Devices according to IEC 60601-1 as well as the Essential Requirements according to MDR 2017/745 and IVDR 2017/746, BAYOOSOFT Risk Manager has a fully integrated Requirements Engineering module to support the traceability requirements of IEC 62304. The intuitive clinical evaluation approach systematically supports the process to collect and evaluate clinical data and confirm the performance and effectiveness of medical devices with a final overall analysis. In addition, it is possible to map the area of the medical IT network according to IEC 80001-1:2 via the BAYOOSOFT Risk Manager.
Your development and approval process is accelerated with BAYOOSOFT Risk Manager: You concentrate on the essentials and increase your productivity.
Product category: Cybersecurity, virus protection, intrusion protection, anti-spam and firewalls
BAYOOSOFT Access Manager - Authorization and User Management
The automated and secure self-service solution for the access and identity journey of your employees and customers
In order to provide employees and customers with a true access and identity journey, BAYOOSOFT offers the Access Manager, the fully automated solution around file servers, SharePoint, Active Directory and third-party systems. The web application standardizes the routine tasks of user and authorization management and supports the provision of IT services such as mailboxes, software distribution or telephony. Not only individual tasks, but also entire process chains are thus optimized, whereby the use of resources and error rates are far lower than with manual processing. As a result, operational efforts, e.g. in IT administration, can be sustainably reduced while information security is increased through monitoring, auditing and transparent reporting for those responsible for data in the specialist departments.
The journey is rounded off by the option for employees to reset forgotten passwords themselves without having to contact the service desk - 24 hours a day, seven days a week. The Access Manager Password Reset is easy to use and has an extremely high user acceptance. This allows processes around user and identity management as well as password administration to be designed efficiently and cost-optimized.
In order to provide employees and customers with a true access and identity journey, BAYOOSOFT offers the Access Manager, the fully automated solution around file servers, SharePoint, Active Directory and third-party systems. The web application standardizes the routine tasks of user and authorization management and supports the provision of IT services such as mailboxes, software distribution or telephony. Not only individual tasks, but also entire process chains are thus optimized, whereby the use of resources and error rates are far lower than with manual processing. As a result, operational efforts, e.g. in IT administration, can be sustainably reduced while information security is increased through monitoring, auditing and transparent reporting for those responsible for data in the specialist departments.
The journey is rounded off by the option for employees to reset forgotten passwords themselves without having to contact the service desk - 24 hours a day, seven days a week. The Access Manager Password Reset is easy to use and has an extremely high user acceptance. This allows processes around user and identity management as well as password administration to be designed efficiently and cost-optimized.
Product category: Healthcare information systems / software (HIS), Certification and testing of medical devices, quality assurance
MEDiLEX - The interactive loose-leaf collection for the healthcare sector
MEDiLEX is an interactive reference work that provides you with the latest information on European legislation in the fields of medical devices and in-vitro diagnostics from a single source. It offers you all relevant documents completely in one work.
MEDiLEX is designed as an interactive loose-leaf collection. Compared to printed works, MEDiLEX stands out primarily due to its networked structure. The individual documents are linked to each other with numerous cross-references. Supported by an integrated full text search, MEDiLEX enables you to find the text passages and terms that are important to you quickly and accurately. Tiresome searching is now a thing of the past.
MEDiLEX is designed as an interactive loose-leaf collection. Compared to printed works, MEDiLEX stands out primarily due to its networked structure. The individual documents are linked to each other with numerous cross-references. Supported by an integrated full text search, MEDiLEX enables you to find the text passages and terms that are important to you quickly and accurately. Tiresome searching is now a thing of the past.
Product category: Certification and testing of medical devices, quality assurance
Regulatory Affairs, Risk Management & QMS
Medical software development always needs to satisfy individual customer requirements and strict legal and regulatory specifications. In order to cover all required activities BAYOOMED offers you support far beyond the actual software development:
- Due diligence services for medical devices, mobile medical applications and medical software
- Quality Management System (QMS) according to ISO 13485 (preparation of the complete QMS, regulatory consulting & mentoring, external QMB, selection and communication of the accredited authority / Notified Body, internal audits, audit preparation & audit support)
- Risk management according to ISO 14971
- Usability / Human Factors Engineering
- Clinical evaluation
- Cybersecurity risk analysis according to FDA and MDCG guidelines
- Creation, maintenance and review of technical documentation, DHF, DMR & DHR
- Controlling, quality assurance & coordination of external software and hardware providers (on-site, near- & off-shore)
- Training & Consulting
Product category: Certification and testing of medical devices, quality assurance
Legal Manufacturer Services
BAYOOCARE - Health Solutions
We support you in placing your Mobile Medical App, DiGA and medical software on the market.
We place medical products on the market in accordance with ISO 13485 and IEC 62304. Our service ranges from regulatory affairs and quality assurance measures to post-market surveillance
Service:
We support you in placing your Mobile Medical App, DiGA and medical software on the market.
We place medical products on the market in accordance with ISO 13485 and IEC 62304. Our service ranges from regulatory affairs and quality assurance measures to post-market surveillance
Service:
- Preparation and maintenance of declarations of conformity for medical devices
- DIMDI registration
- DiGA registration
- Provision of the safety officer
- Product liability
- FDA approval (USA)
- CE Marking (EU)
- International market launch & distribution
- Support
- Post-Market Surveillance
- Vigilance
- Post-Market Clinical Follow-Up
- Pharmacovigilance Support
Our trade marks
BAYOOCARE
BAYOOMED
BAYOOSOFT
About us
Company portrait
About BAYOOCARE and BAYOOMED
The experts at BAYOOCARE GmbH ensure that medical products are brought to international markets. The subsidiary of BAYOONET AG is responsible for regulatory affairs, approval and further monitoring of products after they have been placed on the market. Together with the expertise of BAYOOMED, the division implements projects that fulfil the highest standards.
BAYOOMED is specialized in the development of mobile medical apps and medical software solutions according to IEC 62304. With almost ten years of project experience in the medical technology and pharmaceutical environment, the ISO 13485 certified business unit of BAYOONET AG is one of the most experienced medical software developers in Europe. More than 800 pharmaceutical and medical technology customers have already benefited from the company's expertise in handling medical device classes I-III.
ANDROID & IOS
We have expertise in the development of MHEALTH / EHEALTH applications under iOS (iPhone & iPAD) and Android in medical device classes I-III as well as software safety classes A-C III and support product developers and innovators in the pharmaceutical and medical technology industry.
Certified according to ISO 13485
We are certified according to ISO 9001 and ISO 13485 by TÜV Hessen and live our quality standards: we want to implement sustainable software solutions for you. We accompany you in all phases of the product life cycle:
We invite you to inform yourself about our service portfolio in the field of medical software development according to IEC 62304 (medical software and medical apps) as well as about our products BAYOOSOFT Risk Manager and Medilex. You can meet us personally as an exhibitor and speaker at medical trade fairs and congresses such as MEDICA, Medconf, conhIT, Medtech Pharma Kongress, MEDTEC Stuttgart, Medical Device Forum of TÜV Süd, Medical App Congress, as well as at industry-specific events of the Chambers of Industry and Commerce, the American Chamber of Commerce or at various universities.
The experts at BAYOOCARE GmbH ensure that medical products are brought to international markets. The subsidiary of BAYOONET AG is responsible for regulatory affairs, approval and further monitoring of products after they have been placed on the market. Together with the expertise of BAYOOMED, the division implements projects that fulfil the highest standards.
BAYOOMED is specialized in the development of mobile medical apps and medical software solutions according to IEC 62304. With almost ten years of project experience in the medical technology and pharmaceutical environment, the ISO 13485 certified business unit of BAYOONET AG is one of the most experienced medical software developers in Europe. More than 800 pharmaceutical and medical technology customers have already benefited from the company's expertise in handling medical device classes I-III.
ANDROID & IOS
We have expertise in the development of MHEALTH / EHEALTH applications under iOS (iPhone & iPAD) and Android in medical device classes I-III as well as software safety classes A-C III and support product developers and innovators in the pharmaceutical and medical technology industry.
Certified according to ISO 13485
We are certified according to ISO 9001 and ISO 13485 by TÜV Hessen and live our quality standards: we want to implement sustainable software solutions for you. We accompany you in all phases of the product life cycle:
- Establishing validated and verifiable requirements
- Preparation of the specifications and requirements specification
- Software Architecture and Design
- Development of critical modules or the entire application
- Revision of existing codes
- Creation of a QM system for software
- Hardware connection (e.g. laser, X-ray, blood pressure, ultrasound, imaging, ventilation, OP technology & facility, ...)
- Training of internal software developers (hands-on training and code review)
- Advice on approval problems with medical software products
- Classification Classification
- Risk management according to ISO 14971
- Validation and verification
- Unit testing and manual tests
- Preparation of the technical documentation
- Publication in AppStores
- Legal advice & Due Dilligence
- CE marking/FDA approval
- Market monitoring
We invite you to inform yourself about our service portfolio in the field of medical software development according to IEC 62304 (medical software and medical apps) as well as about our products BAYOOSOFT Risk Manager and Medilex. You can meet us personally as an exhibitor and speaker at medical trade fairs and congresses such as MEDICA, Medconf, conhIT, Medtech Pharma Kongress, MEDTEC Stuttgart, Medical Device Forum of TÜV Süd, Medical App Congress, as well as at industry-specific events of the Chambers of Industry and Commerce, the American Chamber of Commerce or at various universities.