Guide to German Medtech Companies 2021

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Name · BAYOONET AG Address/P.O. Box Postal Code/City State Contact Person Telephone Fax Email Website Founded (year)

· · · · · · · · ·

Europaplatz 5 64293 Darmstadt Hesse Stefan Becher +49-6151-8618-0 +49-6151-8618-150 2001

Areas of Activity · l Medical l Healthcare l Application l Software

BAYOOMED medical software BAYOOMED is the medical software division of BAYOONET AG and specialises in the development of medical apps and medical (standalone) software. BAYOOMED is one of the most experienced medical software engineering companies in Europe, serves more than 800 customers, and has more than 25 years of extensive project experience in software development in the regulated pharmaceutical and medical industry.

mHealth/eHealth BAYOOMED has expertise in the development of mHealth/eHealth applications in iOS (iPhone & iPAD) and Android for the medical device classes I, IIb, and III as well as for the software safety classes B & C.

ISO 13485 certified We are certified by TÜV Hessen according to ISO 9001 and ISO 13485 and develop software in accordance with IEC 62304. We support our customers in all softwareproduct lifecycle phases for standalone-software, embedded solutions, and medical apps:

Member of

·· 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 providers (off-shore development) ·· training of internal software developers (hands-ontraining and code review) ·· development of critical modules or the entire application ·· creation of a QM system for software ·· hardware connectivity (e.g. laser, radiography, blood pressure, ultrasound, imaging, ventilation, surgical technique & facility, etc.) ·· 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

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