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Regulation

Whether it's the European Medical Device Directive (MDD) or other international regulations. It is important for the medical device industry to keep abreast of the latest regulatory developments.

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942 Following
Nataliya Noreika
Regina Preysing
Markus Selent
Alexander Haffelder
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Posts - that's to be discovered on the topic (33)

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MedtecLIVE

May 15, 2025

From Burden to Breakthrough: How Quality Management Becomes Your Competitive Edge

Learn practical strategies for converting compliance requirements into business opportunities, from systematic customer needs analysis to AI-powered process optimization.
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MedtecLIVE

April 16, 2025

AI in Healthcare: Balancing Innovation with Safety Under New Regulations

The new EU AI Act will increase regulation of artificial intelligence in healthcare, presenting organizations with the complex challenge of balancing innovation with regulatory requirements.
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MedtecLIVE

March 27, 2025

Bridging the Gap: How Industry-Clinic Platforms are Reshaping Medical Device Development

The medical device industry faces unprecedented challenges. Discover how innovative industry-clinic platforms are reshaping medical device development, enabling structured collaboration, and maintaining innovation momentum despite regulatory hurdles.
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Metecon GmbH

February 17, 2025

The ABCs of Product Lifecycle Reporting under the MDR – How to Stay on Track!

The requirements of the MDR for the documentation of medical devices are complex. However, with the right strategy, it’s not rocket science to efficiently implement all phases – from clinical evaluation to post-market surveillance.
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Metecon GmbH

January 27, 2025

The Perfect Combination: RIM System and Regulatory Services

Implementing a RIM system? Even the best software isn’t enough on its own. Rely on the perfect combination of a technological system and human expertise.
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be-on-quality GmbH

January 24, 2025

You Develop Medical Devices - We Handle The Rest

Our business areas - expertise for the success of your medical devices In a constantly changing and highly regulated industry, our team of experts offers customized solutions to bring your medical devices to market safely and efficiently. Our services include:
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JÜKE Systemtechnik GmbH

September 2, 2024

From development to product launch

From development to product launch, we guide you through the complex world of regulatory affairs. Find out how our comprehensive quality and risk management and our expertise in standard-compliant documentation ensure your success. Find out more!
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Keller Schneider Patentanwalts GmbH

June 12, 2024

IP due diligence check

In classic M&A agreements, for example when acquiring a company, industrial property rights (patents, utility models, trade marks and/or designs) are regularly part of the subject matter of the agreement. The same applies to licence agreements.

MedtecLIVE 2024
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MedtecLIVE

June 10, 2024

‘Conformity to standards means that everything relating to the process is documented’

According to the Federal Office for Drugs and Medical Devices, risk reports have multiplied, often due to ‘inadequate manufacturing processes’. It’s important to make sure that processes are validated to avoid errors. We spoke about this with expert Robert Schreiner from Novoplast Schlauchtechnik.

MedtecLIVE 2024
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FSQ Experts - A Brand of Wertefest GmbH

May 28, 2024

We answer your questions about regulatory affairs!

Have you defined the intended use of your medical device correctly? Is the device clarification unclear? Is your regulatory strategy adequate? Have you started compiling your technical file? Confused by too many questions?! We are here to give you the answers. Book a free consultation slot now!

MedtecLIVE 2024

Providers (19)

Früh Verpackungstechnik AG

We offer comprehensive services from a single source - in the highest quality, for the best possible protection of products, people and customers. From the development of customized solutions to the production of packaging materials and contract packaging to qualification and documentation.

Fehraltorf, Switzerland

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JÜKE Systemtechnik GmbH

JÜKE is an experienced service provider for product development, contract manufacturing and regulatory affairs for companies in the fields of medical technology, analytics, biotechnology, laboratory technology and photonics.

Altenberge, Germany

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ALLTEC Angewandte Laserlicht Technologie GmbH

FOBA Laser Marking + Engraving (brand of ALLTEC Angewandte Laserlicht Technologie GmbH) develops and supplies advanced laser technology for industrial direct part marking and engraving.

Selmsdorf, Germany

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seleon GmbH

seleon GmbH has been a leading service partner for medical technology companies in Central Europe for 26 years, focusing on the areas of development, consulting and production.

Heilbronn, Germany

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MedtecLIVE

MedtecLIVE is the leading trade fair in Europe for the development and manufacture of medical technology

Nürnberg, Germany

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Corscience GmbH & Co. KG

Defibrillationslösungen. Schneller. Corscience ist der herstellerunabhängige Partner für Defibrillation und Monitoring. Wir bieten Engineering- und Beratungsleistungen sowie etablierte und anpassbare Lösungen. Damit unterstützen wir Sie dabei, Ihre Lösungen schneller auf den Markt zu bringen.

Erlangen, Germany

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MedicalMountains GmbH

MedicalMountains GmbH is a network that connects and supports players in the medical technology sector. We promote the exchange between companies, research and politics and create platforms for dialogue. We support all players in the medical technology sector.

Tuttlingen, Germany

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Logo Eurofins - Medical Device Testing, Consulting & Sterile Packaging

Eurofins - Medical Device Testing, Consulting & Sterile Packaging

Eurofins is a world leader in the testing, cleaning, packaging and sterilization of medical devices. The consulting team has expertise in a wide range of products and manufacturing processes to assess the biological risks of a new product design or process change.

Planegg / München, Germany

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CleanControlling Medical GmbH & Co. KG

CleanControlling Medical GmbH & Co. KG is your partner as an accredited and ZLG and GLP accepted testing laboratory for biological and microbiological-hygienic testing of medical devices.

Emmingen-Liptingen, Germany

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