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Regulation

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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.

Nataliya Noreika
Regina Preysing
Markus Selent
Alexander Haffelder
929 Following
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Posts - that's to be discovered on the topic (30)

Logo Metecon GmbH
Metecon GmbH
February 17, 2025
Innovation Expo

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
Innovation Expo

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
Innovation Expo

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:
Logo JÜKE Systemtechnik GmbH
JÜKE Systemtechnik GmbH
September 2, 2024
Service

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
Service

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
Interview

‘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
Logo FSQ Experts - A Brand of Wertefest GmbH
FSQ Experts - A Brand of Wertefest GmbH
May 28, 2024
Service

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
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NMI Naturwissenschaftliches und Medizinisches Institut
May 27, 2024
Service

MIK - MDR- & IVDR-Competence Centre

As a competence center, MIK offers consulting and development capacities and is oriented towards the needs and requirements of the industry. The holistic approach of MIK accompanies you on the way from the idea to the certification of your innovative products.

MedtecLIVE 2024
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novineon CRO GmbH
May 23, 2024
Market & Industry

Experts of novineon CRO

Meet our experts at booth 1-316 and benefit from their extensive know-how on IVDR, international approvals & FDA and clinical trials. We look forward to sharing our experience with you.

MedtecLIVE 2024
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Pantec Biosolutions AG
May 15, 2024
Best practice

Risk-based system architecture

In its Appendix I the MDR requires the development of safe, effective medical products. During development, there's a risk of not specifying the product correctly or specifying it to an exaggerated extent. Our systematic approach to a risk-based system architecture provides a remedy and saves costs.

MedtecLIVE 2024

Past events (3)

Exhibitor Presentation
Jun 20, 2024 10:30 AM - 11:00 AM | Exhibitor Forum (1-916)
MedtecLIVE 2024

The Importance of Transparency in Regulatory Documentation

MedtecLIVE 2024

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Logo Enterprise Ireland
H
Impulse talks & discussion
Jun 19, 2024 3:00 PM - 4:30 PM | Forum (1-331)
MedtecLIVE 2024

"Speed up time to market" - digitalisation and AI for a faster and safer regulatory process

MedtecLIVE 2024

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Logo Medtech Cluster Alliance D-A-CH
Frauke Wurmböck
H
Alexander Fink
Michael M. Kania
Dr. Andreas Purde
Prof. Dr. Christian Johner
Dr. Claudia Luther
Dr. Frank Miermeister
Exhibitor Presentation
Jun 19, 2024 1:30 PM - 2:00 PM | Exhibitor Forum (1-916)
MedtecLIVE 2024

Everyone is talking about digitalization - we are doing it, learnings and best practices from customer projects

MedtecLIVE 2024

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Peter Hartung

Providers (19)

Logo Früh Verpackungstechnik AG

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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Logo JÜKE Systemtechnik GmbH

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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Logo ALLTEC Angewandte Laserlicht Technologie GmbH

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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Logo seleon GmbH

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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Logo MedtecLIVE

MedtecLIVE

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

Nürnberg, Germany

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Logo Corscience GmbH & Co. KG

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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Logo MedicalMountains GmbH

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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Logo CleanControlling Medical GmbH & Co. KG

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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