BAYOOMED

We develop your medical software

With our experts from BAYOOMED, we at YOOme are one of the most experienced medical software developers in Europe. As a medical device manufacturer, you will benefit from our expertise in embedded software, cybersecurity, cloud-based healthcare solutions, and Digital Health and Care Applications (DiGA, DiPA). We develop your medical software and apps according to the IEC 62304 standard for medical device classes I, IIa, IIb and III as well as software security classes A, B and C.

Our quality management processes are certified according to ISO 13485:2016 by TÜV Hessen and are an expression of our passion for sustainable corporate solutions. This quality policy commits us to develop safe and reliable as well as innovative and user-centric software solutions.

We draw our knowledge of the regulated medical and pharmaceutical sectors from over 10 years of project experience.

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Years of experience in the medical and pharmaceutical environment
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satisfied Medtech customers
Zertifikat ISO 13485:2016, Geltungsbereich: Analyse, Design, Entwicklung, Vertrieb, Schulung, Beratung und Support von medizinischen Softwarelösungen und Medizinproduktesoftware

  • Are you looking for a partner to support you in product development – from requirements management to validation and verification?

  • Do you need a software solution that fulfills all cybersecurity requirements and supports you in compliance with regulatory standards?

  • Standards and regulations are not your area of expertise? Fortunately, our experts have the overview for you, as with ISO 27001, ISO 9001 and ISO 13485, and are experienced with MDSAP.

  • Are you looking for a partner to support you in product development – from requirements management to validation and verification?

  • Do you need a software solution that fulfills all cybersecurity requirements and supports you in compliance with regulatory standards?

  • Standards and regulations are not your area of expertise? Fortunately, our experts have the overview for you, as with ISO 27001, ISO 9001 and ISO 13485, and are experienced with MDSAP.

Our services for your success

We develop with passion and innovation

Whether medical software or mobile medical apps (mHealth / eHealth) for iOS and Android – we develop your medical device in classes I, IIa, IIb and III as well as security classes A, B and C in compliance with IEC 62304 standards.

Keeping an eye on all of the regulatory requirements: We consult and support you

From clinical evaluation according to regulation 2017 / 745 (MDR) and risk management to the quality management system (QMS). We will make your processes work – or consult you on the right implementation.

Software solutions for every use case

Do you want to launch a new DiGA or DiPA? Or are you looking for an innovative software solution to be integrated into a medical device? We have created solutions for more than 800 medtech customers – we realize your project.

An overview of all services for your medical device

Medical Software Development & Apps

Quality management

Fast prototyping

Requirements Engineering

Risk management

Cybersecurity

DMR/DHF

(Software) validation

Hosting- & Cloud-Services

Post-Market-Surveillance (PMS)