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BAYOONET AG
Europaplatz 5,
64293
Darmstadt
Germany
Germany
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Media files
BAYOONET AG
WS: Das Medizinprodukterecht-Durchführungsgesetz (MPDG)
BAYOONET AG
WS: Risiken im Softwarelebenszyklus IEC 62304 – toolgestützte Traceability
BAYOONET AG
WS: Den Prozess Klinische Bewertung durch Toolunterstützung beschleunigen
BAYOONET AG
WS: Zulassung KI-basierter medizinscher Software
WS: DiGA - der sicher Weg zur digitalen Gesundheitsanwendung
BAYOONET AG
WS: Normkonforme Mobile Medical Apps und medizinische Software: Eine kurze Einführung
BAYOONET AG
Contact
Christine Erb
Medical Consultant & Solution Representative
BAYOOSOFT
BAYOOSOFT
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16 Nov 2020
Topic
10:30 - 11:00
State of the art engineering of medical software and Mobile Medical Apps according to MDR, FDA and IEC 62304 requirements
The presentation gives a small insight into the medical software engineering process, while focusing on the following five main questions:
- What are the requirements for medical software and Mobile Medical Apps to fulfill the MDR?
- What should be considered when designing a software architecture that should meet the MDR, GDPR and FDA Cybersecurity requirements?
- What is the most efficient way to engineer and maintain a medical software that should be released in multiple regulated markets?
- What are the main criteria to decide if a medical software component should be engineered from scratch or based on an unvalidated SOUP component?
- Should multiplatform apps for Android and iOS devices be engineered native or by means of a cross-platform framework like Xamarin?
17 Nov 2020
Topic
10:30 - 11:00
State of the art engineering of medical software and Mobile Medical Apps according to MDR, FDA and IEC 62304 requirements
The presentation gives a small insight into the medical software engineering process, while focusing on the following five main questions:
- What are the requirements for medical software and Mobile Medical Apps to fulfill the MDR?
- What should be considered when designing a software architecture that should meet the MDR, GDPR and FDA Cybersecurity requirements?
- What is the most efficient way to engineer and maintain a medical software that should be released in multiple regulated markets?
- What are the main criteria to decide if a medical software component should be engineered from scratch or based on an unvalidated SOUP component?
- Should multiplatform apps for Android and iOS devices be engineered native or by means of a cross-platform framework like Xamarin?
11:00 - 11:30
The Medical Devices Law | Implementation Act (MPDG)
The Medical Devices Law - Implementation Act (MPDG), which will replace the MPG for medical devices and in-vitro diagnostics, includes a proud 99 paragraphs.
The article focuses on:
The article focuses on:
- the supplementary notification requirements
- the German Information and Database System on Medical Devices (DMIDS)
- Notified Bodies
- extended powers of the BfArM in the field of vigilance tasks
- as well as regulatory powers and transitional provisions.
18 Nov 2020
Topic
11:00 - 11:30
State of the art engineering of medical software and Mobile Medical Apps according to MDR, FDA and IEC 62304 requirements
The presentation gives a small insight into the medical software engineering process, while focusing on the following five main questions:
- What are the requirements for medical software and Mobile Medical Apps to fulfill the MDR?
- What should be considered when designing a software architecture that should meet the MDR, GDPR and FDA Cybersecurity requirements?
- What is the most efficient way to engineer and maintain a medical software that should be released in multiple regulated markets?
- What are the main criteria to decide if a medical software component should be engineered from scratch or based on an unvalidated SOUP component?
- Should multiplatform apps for Android and iOS devices be engineered native or by means of a cross-platform framework like Xamarin?
19 Nov 2020
Topic
10:30 - 11:00
The Medical Devices Law | Implementation Act (MPDG)
The Medical Devices Law - Implementation Act (MPDG), which will replace the MPG for medical devices and in-vitro diagnostics, includes a proud 99 paragraphs.
The article focuses on:
The article focuses on:
- the supplementary notification requirements
- the German Information and Database System on Medical Devices (DMIDS)
- Notified Bodies
- extended powers of the BfArM in the field of vigilance tasks
- as well as regulatory powers and transitional provisions.
14:40 - 15:10
State of the art engineering of medical software and Mobile Medical Apps according to MDR, FDA and IEC 62304 requirements
The presentation gives a small insight into the medical software engineering process, while focusing on the following five main questions:
- What are the requirements for medical software and Mobile Medical Apps to fulfill the MDR?
- What should be considered when designing a software architecture that should meet the MDR, GDPR and FDA Cybersecurity requirements?
- What is the most efficient way to engineer and maintain a medical software that should be released in multiple regulated markets?
- What are the main criteria to decide if a medical software component should be engineered from scratch or based on an unvalidated SOUP component?
- Should multiplatform apps for Android and iOS devices be engineered native or by means of a cross-platform framework like Xamarin?
Our range of products
Product categories
- 06 Information and communication technology
- 06.02 mHealth, mobile IT, wireless technologies (Bluetooth, WI-FI)
mHealth, mobile IT, wireless technologies (Bluetooth, WI-FI)
- 06 Information and communication technology
- 06.03 Wearable technologies, smart textiles
Wearable technologies, smart textiles
- 06 Information and communication technology
- 06.04 eHealth, telemedicine / telematics / telemetry
eHealth, telemedicine / telematics / telemetry
- 06 Information and communication technology
- 06.05 Administrative information systems / software
- 06.05.01 Healthcare information systems / software (HIS)
Healthcare information systems / software (HIS)
- 06 Information and communication technology
- 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 Information and communication technology
- 06.06 Medical information systems / software
- 06.06.02 Internet / web portals, healthcare portals
Internet / web portals, healthcare portals
- 06 Information and communication technology
- 06.06 Medical information systems / software
- 06.06.03 Intranet software
Intranet software
- 06 Information and communication technology
- 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: Healthcare information systems / software (HIS), Certification and testing of medical devices, quality assurance
The efficient way to technical documentation
BAYOOSOFT Risk Manager has been the world's leading and validated software solution for the creation of technical documentation since 2000. In addition to the creation of risk management files according to ISO 14971:2012, the Usability Engineering File according to IEC EN 60601-1-6 / IEC 62366, the Conformity Report for Medical Electrical Equipment according to IEC 60601-1, 3.1 edition and the Basic Requirements according to MDR 2017/745 and IVDR 2017/746, BAYOOSOFT Risk Manager also has a fully integrated Requirements Engineering module. The intuitive approach with the extension "Clinical Evaluation" supports the process of systematically collecting and evaluating clinical data in order to confirm the performance and effectiveness of medical devices with the final overall analysis. In addition, it is possible to map the area of the medical IT network according to IEC 80001-1:2010 via the BAYOOSOFT Risk Manager.
In a clearly structured environment, the acquired knowledge grows across projects in the self-learning knowledge database of the BAYOOSOFT Risk Manager. The information is made available to authorised employees throughout the company, a loss of knowledge due to employee turnover is avoided, and particularly effective measures are identified and suggested. Your development and approval process is accelerated with BAYOOSOFT Risk Manager: You spend your time on the content, not the form.
In a clearly structured environment, the acquired knowledge grows across projects in the self-learning knowledge database of the BAYOOSOFT Risk Manager. The information is made available to authorised employees throughout the company, a loss of knowledge due to employee turnover is avoided, and particularly effective measures are identified and suggested. Your development and approval process is accelerated with BAYOOSOFT Risk Manager: You spend your time on the content, not the form.
Product category: mHealth, mobile IT, wireless technologies (Bluetooth, WI-FI), eHealth, telemedicine / telematics / telemetry, Medical Apps and App Stores
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
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), 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 Manufaturer Services
BAYOOCARE – Health Solutions
We support you in bringing your Mobile Medical App, DiGA and medical software to market.
We launch medical products on the market according to ISO 13485 and IEC 62304. Our services range from regulatory affairs and quality assurance measures to post-marketing surveillance.
Service
We support you in bringing your Mobile Medical App, DiGA and medical software to market.
We launch medical products on the market according to ISO 13485 and IEC 62304. Our services range from regulatory affairs and quality assurance measures to post-marketing surveillance.
Service
- Creation 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 Introduction & Distribution
- Technical support (1st, 2nd & 3rd level)
- Post-Market Surveillance
- Vigilance
- Post-Market Clinical Follow-Up
- Pharmacovigilance
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:
- 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.
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.