Medical Products Supplies Companies

Europaplatz 5D, 64293 Darmstadt
Germany
Telephone +49 6151 86180
Fax +49 6151 8618150
medica@bayoo.net
http://www.bayoomed.com

Product Categories

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
06.06.03 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

We develop Medical Apps
Development of medical apps with CE marking

07 Medical Services and Publications
07.16 Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Riskmanager – the validated approval accelerator

Our products

Product category: Medical Apps and App Stores
We develop Medical Apps
Are you looking for support in the development of your medical software or medical app? For 18 years we have specialized in the conception and implementation of software solutions. For the pharmaceutical and medical technology sector we implement software projects according to the valid regulatory standards IEC 62304, ISO 14971 and IEC 60601-1-6 / EN 62366. Our focus is the development of mobile applications for iPhone, iPad, Android Phones & Tablets and Windows Mobile devices.

We support you in all product life cycle phases:

Requirements Engineering
risk management
software engineering
usability engineering
testing
rollout
Publication in App Stores
CE marking / FDA approval
Market observation.

We plan, develop, test and document medical apps according to your specifications, taking into account the applicable regulatory requirements for medical devices.

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Product category: Medical Apps and App Stores
Development of medical apps with CE marking
BAYOOMED specializes in the development of medical apps and medical (standalone) software. With over 250 person years of project experience in software development in the regulated medical and pharmaceutical environment and more than 800 medical technology customers, we are among the most experienced medical software developers in Europe.

ANDROID & IOS
We have expertise in the development of MHEALTH / EHEALTH applications under iOS (iPhone & iPAD) and Android in the medical device classes I-III and the software security classes A-C III and support product developers and innovators from the pharmaceutical and medical technology industries.

Product category: Certification and testing of medical devices, quality assurance
Riskmanager – the validated approval accelerator
The Riskmanager software solution, which is market-leading and validated worldwide, generates technical documentation conveniently and reliably for medical devices and in-vitro diagnostics. Sustainable and audit-proof documentation and the medical device classifier support the process-oriented approach of risk management and thus contribute to the safety of the medical device for patients and users. With the field-proven reports, you can create a standard-compliant risk management file in order to place medical devices on the market without any problems.

The validated approval accelerator Riskmanager supports you in the convenient generation of technical documentation for your medical devices. In addition to the creation of risk management files in accordance with ISO 14971, the usability engineering file in accordance with EN 62366 / IEC EN 60601-1-6, the conformity report for medical electrical devices in accordance with IC 60601-1, 3.1 edition and the basic requirements in accordance with MDR 2017/745 and IVDR 2017/746, the Risk Manager also has a fully integrated requirements engineering module with traceability function and a risk management module for medical IT networks in accordance with IEC 80001-1. Risk Manager meets the requirements of FDA 21 CFR Part 11.

Self-explanatory: Intuitive user guidance
Efficient: 62% faster to approval
Intelligent: Self-learning system
Ready for use: preconfigured standard processes
Conformity: Audit-safe technical documentation
Market-proven: Over 3,000 product files generated since 1998

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About Us

Company details
BAYOOMED specializes in the development of medical apps and medical (standalone) software. With over 250 person years of project experience in software development in the regulated medical and pharmaceutical environment and more than 800 medical technology customers, we are among the most experienced medical software developers in Europe.

We have expertise in the development of MHEALTH / EHEALTH applications under iOS (iPhone & iPAD) and Android in medical device classes I-III and software security classes A-C III and support product developers and innovators from the pharmaceutical and medical technology industries.

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