BAYOONET AG of Darmstadt at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine
Manufacturers Service

BAYOONET AG

Robert-Bosch-Str. 7, 64293 Darmstadt
Germany
Telephone +49 6151 8618-0
Fax +49 6151 8618-150
medica@bayoo.net

Hall map

MEDICA 2018 hall map (Hall 15): stand C51

Fairground map

MEDICA 2018 fairground map: Hall 15

Contact

Stefan Becher

Vorstand

Phone
+49 6151 8618 0

Email
medica@bayoo.net

Alexander Steffen

Director Project Development

Phone
+49 6151 8618 220

Email
medica@bayoo.net

Benjamin Klein

Medical Project Lead

Phone
+49 6151 8618 151

Email
medica@bayoo.net

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
  • 06.06.03  Intranet software

Intranet software

  • 06  Information and Communication Technology
  • 06.06  Medical information systems / software
  • 06.06.04  Medical Apps and App Stores
  • 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: Medical Apps and App Stores

Medical Apps & Medical Software Engineering by BAYOOMED

AYOOMED is specialized in the development of medical apps and medical (standalone) software. With more than 250 person years of project experience in software development in the regulated medical and pharmaceutical environment and over 800 medical & pharma customers, we are among the most experienced medical software developers in Europe.
We engineer MHEALTH / EHEALTH applications under iOS (iPhone & iPAD) and Android according to IEC 62304 and support product developers and innovators from the pharmaceutical and medical technology sectors in all phases of software product lifecycle. We have experience in software engineering in the medical device classes I, IIb, and III and the software security classes B and C.
BAYOOMED is highly professional in the regulated CE & FDA environment. We design, develop, test, validate and document medical software and medical apps in accordance with the regulatory standards IEC 62304, ISO 14971, IEC 62366 as well as the FDA Guidance for Mobile Medical Applications. We could offer Due Dilligence Services for medical device classifications, usability engineering, risk management, technical documentation and FDA and CE registration.
Our Quality management processes certified by TÜV Hessen according to ISO 13485 are a testament to our passion for sustainable solutions and distinct customer focus.
Our customers have been entrusting us with their sensitive projects for 17 years and have recommended our services many times. We are delighted about this and it also gives us further motivation to show each and every new customer what we can do for them.

More Less

Product category: Certification and testing of medical devices, quality assurance

Qware® Riskmanager

Qware® Riskmanager is the worldwide market-leading and validated software solution for the technical documentation for medical devices. Qware® Riskmanager is compliant with FDA 21 CFR Part 11 and creates the risk management file (ISO 14971), the usability engineering file (EN 62366), the conformity report for medical electrical equipment (IEC 60601-1) as well as the essential requirements in accordance with MDR 2017/745 and IVDR 2017/746. With its integrated requirements engineering module and its self- learning knowledge database, that shares the relevant knowledge throughout the whole company, you get a cost effective and audit compliant documentation with a mouse click.
Benefits:

- validated solution based on the GAMP 5 Guidelines for Computer-Aided Validation
- field-tested solution for 17 years
- current regulatory requirements
- process-oriented user guidance and reliable
- focus on issues with regard to contents
- prevention of redundant data
- efficient and comfortable working through automation

More Less

About us

Company details

BAYOOMED is specialized in the development of medical apps and medical (standalone) software. With more than 250 person years of project experience in software development in the regulated medical and pharmaceutical environment and over 800 medical & pharma customers, we are among the most experienced medical software developers in Europe.
We engineer MHEALTH / EHEALTH applications under iOS (iPhone & iPAD) and Android according to IEC 62304 and support product developers and innovators from the pharmaceutical and medical technology sectors in all phases of software product lifecycle. We have experience in software engineering in the medical device classes I, IIb, and III and the software security classes B and C.
BAYOOMED is highly professional in the regulated CE & FDA environment. We design, develop, test, validate and document medical software and medical apps in accordance with the regulatory standards IEC 62304, ISO 14971, IEC 62366 as well as the FDA Guidance for Mobile Medical Applications.

We support our customers in all software-product lifecycle phases:
• setting up evaluable and verifiable requirements
• creation of the specification and the requirement specification
• software architecture and design
• Controlling of external soft- and hardware service provider (off-shore development)
• training of internal software developers (Hands-On-Training and Code review)
• development of critical modules or the entire applica-tion
• creation of a QM system for software
• hardware connectivity (e.g. laser, radiography, blood pressure, ultrasound, imaging, ventilation, surgical technique & facility, …)
• risk-management in accordance with ISO 14971
• validation and verification
• unit-testing and manual test
• creation of the technical documentation
• release in app-stores
• CE Mark/ FDA approval
• approval & market observation
Our Quality management processes certified by TÜV Hessen according to ISO 13485 are a testament to our passion for sustainable solutions and distinct customer focus.

Since more than 17 years our product Qware® Riskmanager is the worldwide market-leading software solution for the technical documentation for medical devices. Qware® Riskmanager is compliant with FDA 21 CFR Part 11 and creates the risk management file (ISO 14971), the usability engineering file (EN 62366), the conformity report for medical electrical equipment (IEC 60601-1) as well as the essential requirements in accordance with MDR 2017/745 and IVDR 2017/746. With its integrated requirements engineering module and its self- learning knowledge database, that shares the relevant knowledge throughout the whole company, you get a cost effective and audit compliant documentation with a mouse click.
Qware® Riskmanagers is validated based on the GAMP 5 Guidelines for Computer-Aided Validation. The market-leading software solution has gone through the validation process as Category 4 software, going through everything from requirements through configuration specifications to acceptance testing.
Our customers have been entrusting us with their sensitive projects for 17 years and have recommended our services many times. We are delighted about this and it also gives us further motivation to show each and every new customer what we can do for them.

More Less