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 &)
- 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.