MedtecLIVE

Master Medical Device Compliance: IEC 60601, IEC 62304 & Cybersecurity

Struggling with safety standards, software processes or cybersecurity requirements? Get clear, practical guidance to finally move your product towards approval.

JÜKE Systemtechnik GmbH

February 19, 2024

Regulatory Affairs

Benefit from the extensive and long-standing experience of our experts: We accompany the entire process, from consulting to approval requirements, standard-compliant development and production through to the certification of medical devices.

MedtecLIVE 2024

MED engineering DACH

March 11, 2026

Product

The MED engineering Archive – Expert Knowledge On Demand!

Years of accumulated expertise for designers and developers of medical devices – now available digitally, anytime and anywhere. Never miss a topic again: from medical electronics and device components to robotics, AI, and regulatory approval.

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!

USE-Ing. GmbH

April 27, 2026

Usability Engineering in Medical Technology

Usability Engineering is a key success factor for safe, regulatory‑compliant, and economically successful medical devices. Learn how a standards‑compliant process based on IEC 62366‑1 reduces use‑related risks, satisfies Notified Bodies, and sustainably supports your MDR strategy.

MedtecLIVE

March 3, 2023

Market & Industry

Amendments to the Medical Devices Regulation adopted

The European Parliament voted positively on the draft amendment to the Medical Device Regulation (MDR). Since the Council already gave its approval at the end of January, the amendment has now been de facto adopted. Manufacturers are thus given more time to transfer existing products to the MDR.

GBA Group MedTech Solutions

April 16, 2026

Welcome to GBA Group MedTech Solutions

Your trusted partner for analytical services, validation, and compliance. We support you in bringing your medical devices to market safely and efficiently while meeting regulatory requirements worldwide.

JÜKE Systemtechnik GmbH

February 4, 2026

Best practice

Outsourcing in medical technology: How strategic partnerships combine innovation, safety, and market success

Outsourcing in medical technology is more than just cost optimization. This article shows how integrated models covering everything from development and production to regulatory compliance reduce risks, shorten time-to-market, and ensure sustainable market success with strong partners.

B&W Engineering GmbH

February 11, 2026

Interview

How does B&W Engineering und Datensysteme GmbH develop cost-efficient and sustainable products?

"Fewer interfaces, more speed, guaranteed market readiness. That's how you gain a competitive edge." Managing Director Sven Siefert in an interview with Handelsblatt.

Providers related to 'Approval' (22)

Nakamo AG

Nakamo develops Regulatory AI Companions for medical device companies. Our solutions transform regulatory change, document comparison and compliance workflows into structured, auditable processes. We help QA & RA teams and executives reduce manual effort and increase decision quality.

Baden, Switzerland

BAYOOSOFT GmbH

Focus on the essentials and increase productivity. Simplify, delegate & automate your management processes in highly regulated areas and critical infrastructures.

Darmstadt, Germany

TÜV Rheinland AG

TÜV Rheinland stands for safety and quality in almost all areas of business and life.

Köln, Germany

GBA Group MedTech Solutions

GBA Group MedTech Solutions supports medical device manufacturers throughout the entire device lifecycle – from concept to market approval and post-market surveillance. We combine regulatory expertise, consulting and testing services to turn complexity into clarity.

Hamburg, Germany

novineon CRO GmbH

novineon CRO is a leading service provider for research and regulatory affairs. For two decades we have been supporting manufacturers of medical devices and in-vitro diagnostics (IVD) in clinical and regulatory affairs related to conformity issues, e.g. clinical evaluation and clinical trials.

Tübingen, Germany

Digital Life Sciences GmbH

Digital Life Sciences GmbH offers innovative and practical solutions in the field of digital document and quality management. We provide targeted support for your digital transformation, including consideration of your regulatory requirements.

Gescher, Germany

USE-Ing. GmbH

We help manufacturers make complex medical technology intuitive and compliant. As experts in Human Factors Engineering and usability, we support you from early analysis to validated usability documentation. Visit us to see how we streamline your HF/UE processes and strengthen product safety.

Stuttgart, Germany

IMM electronics GmbH

IMM electronics GmbH is your E²MS partner for medical technology. We develop and manufacture electronic assemblies and devices in high-mix, low-volume production – from concept to series including logistics and services. Quality, flexibility and 35+ years of experience.

Mittweida, Germany

BYTEC Medizintechnik GmbH

For over 30 years, BYTEC Medizintechnik has been a service provider for the development and production of medical devices for surgery, therapy and diagnostics.

Eschweiler, Germany

May 6, 2026 2:00 PM - 3:00 PM

Events related to 'Approval' (2)

Exhibitor Event

Impulse talks & discussion

Win a Free Ticket for the Usability & Human Factors MeetUp

MedtecLIVE 2026

May 7, 2026 12:00 PM - 1:30 PM | Forum (3-520)