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MedTech · Pharma · Industry 4.0 · High-Tech
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In-depth industry expertise.

We are familiar with the regulatory requirements, quality standards, and process landscapes of our core industries – and develop software and IT solutions that precisely fit your reality.

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01Medical Technology 02Pharma 03Industry 4.0
01
ISO 13485 · IEC 62304
Industry 01

Medical Technology.

Medical technology is one of the most important topics when it comes to health and healing. With advancing digitalization, software development and IT services are gaining increasing importance in this area – associated with special requirements for the protection of patients.

Especially medium-sized manufacturers, who hold the largest market share, face the challenge of reliably meeting both device and software requirements. mediatec.net supports medical device manufacturers in software development and IT services – with a QM system certified according to DIN EN ISO 13485 and working methods according to IEC 62304.

DIN EN ISO 13485 IEC 62304 MDR compliant Risk Management
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02
GMP · EU-GMP Annex 11 / 15
Industry 02

Pharma.

The high-quality manufacturing of medicines and active ingredients is of fundamental importance in the pharmaceutical industry. Where human lives are at stake, additional measures must be taken to ensure maximum safety in handling products.

Quality assurance is regulated by GMP (Good Manufacturing Practice) – also for software and IT systems. We develop strictly according to our QM system and additionally cover the central requirements of EU-GMP Annex 11 and Annex 15.

GMP EU-GMP Annex 11 EU-GMP Annex 15 CSV / Validation
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03
Industry 4.0 · IoT · PLM
Industry 03

Industry & Industry 4.0.

Under the keyword "Industry 4.0", digitalization is advancing with increasingly intelligent embedded systems and, above all, with the "Internet of Things". By networking individual systems and automating work steps, the efficiency of the entire company increases – standardized processes make the integration of new elements easy.

This is precisely where we come in: As experts for ARAS Innovator, we put together the PLM/PDM system that your company truly needs – with individual adaptations and a complete overview of your products, from conception to market entry.

ARAS Innovator PLM / PDM IoT Embedded Systems
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Quote
"Quality is never an accident; it is always the result of intelligent effort."
— John Ruskin
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Your industry, our expertise.

Talk to us about your regulatory requirements, validation projects, or your Industry 4.0 roadmap. Together we will develop the right solution.

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info@mediatec.net
Phone: +49 451 300 96 05-0
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