inotec FEGmbH – Full-service partner for medical technology
Medical devices · IVD · SiMD · SaMD

Full-service partner for manufacturers of medical devices, IVD, SiMD and SaMD

For 30 years, we have been developing medical systems and electronic products for medical technology and IoT companies in Germany and abroad. Certified, reliable and agile. We cover the entire product chain, take care of regulatory approval and, on request, assume the entire risk.

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Services

Think it.
Build it.
Own it.

Our services are not limited to development. On request – also as an OEM partner – we take over complete product lifecycle management, adapt and evolve your products to meet market and customer needs, transfer them into series production, act as the legal manufacturer of your product and help you optimise its costs.

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Quality Management

Certified quality

Our processes, certified to DIN EN ISO 13485, ensure systematic safety and the highest quality – giving you legal and planning certainty throughout the entire product lifecycle. Our core processes comply with, among others:

  • ISO 13485Quality management
  • ISO 14971Risk management
  • IEC 62304Software life cycle
  • IEC 62366Usability
  • IEC 81001-5-1Cybersecurity
  • EU AI Act, GDPRand more
  • MDRCertified AI in medical devices
Quality management
Legal Manufacturer

On request, we act as the manufacturer of your product

As legal manufacturer, we place your medical device or IVD on the market under our name within the meaning of the MDR and assume regulatory responsibility – from technical documentation and conformity assessment to post-market surveillance.

  • MDR / IVDRTechnical documentation
  • CEConformity assessment and marking
  • UDIRegistration and product identification
  • PMSPost-market surveillance and vigilance
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Customers

Satisfied customers

Eppendorf
VivoSensMedical
ADB Airfield Solutions
TomTom
Siemens
Honeywell
nextbike
Webfleet Solutions
Sennheiser
TechniSat
Swiss Timing
Gemalto
About us

Local and international

Development is our passion. We see ourselves as your partner and want to secure your long-term success together with you. That is why we also want to understand your business – so that we can offer you the solutions you really need. Whether medical technology, AI solutions, big data solutions, SiMD, SaMD or non-medical solutions: just ask us!

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Contact

Have we sparked your interest?

Phone +49 341 356 990 23 · info@inotec-feg.de

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