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BAYOONET AG
Europaplatz 5,
64293
Darmstadt
Germany
Germany
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About BAYOOMED and BAYOOCARE
Developing mobile medical apps and medical software solutions in accordance with IEC 62304 is what BAYOOMED specializes in. 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 its technical expertise in dealing with medical device classes I-III.
Bringing medical products to market internationally is guaranteed by the experts at BAYOOCARE GmbH. The subsidiary of BAYOONET AG takes care of regulatory affairs, approval and further monitoring of products after they have been placed on the market. Together with BAYOOMED 's expertise, the division creates project support of the highest standards.
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 and support product developers and innovators from the pharmaceutical and medical technology industries.
Certified according to ISO 13485
We are certified according to ISO 9001 and ISO 13485 by TÜV Hessen and live our quality claim: we want to implement sustainable software solutions for you. We accompany you in all phases of the product life cycle:
Developing mobile medical apps and medical software solutions in accordance with IEC 62304 is what BAYOOMED specializes in. 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 its technical expertise in dealing with medical device classes I-III.
Bringing medical products to market internationally is guaranteed by the experts at BAYOOCARE GmbH. The subsidiary of BAYOONET AG takes care of regulatory affairs, approval and further monitoring of products after they have been placed on the market. Together with BAYOOMED 's expertise, the division creates project support of the highest standards.
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 and support product developers and innovators from the pharmaceutical and medical technology industries.
Certified according to ISO 13485
We are certified according to ISO 9001 and ISO 13485 by TÜV Hessen and live our quality claim: we want to implement sustainable software solutions for you. We accompany you in all phases of the product life cycle:
- Establishment of validatable and verifiable requirements
- Creation of requirements and functional specifications
- Software architecture and design
- Development of critical modules or the whole application
- Revision of existing codes
- Creation of a QM system for software
- Hardware integration (e.g. laser, X-ray, blood pressure, ultrasound, imaging, ventilation, OR technology & setup,...)
- Training of internal software developers (hands-on training and code review)
- Consulting in case of approval difficulties of medical software products
- Classification classification
- Risk management according to ISO 14971
- Validation and verification
- Unit testing and manual testing
- Preparation of technical documentation
- Publication in AppStores
- Legal advice & due diligence
- CE Marking/FDA Approval
- Market monitoring