Update MDR & IVDR

Get an update on the new MDR & IVDR. And find out about the latest developments on the agreement between Switzerland and the EU on Mutual Recognition of Conformity Assessments for Medical Devices (MRA).

Posts - that's to be discovered on the topic (48)

teltec systems ag February 23, 2022
Service Highlight

FOBA Middleware: Laser marking software for easy integration

Choose the easy way: All relevant laser marking parameters can now be centrally controlled with FOBA Middleware! Comprehensive control via one software, only TCP/IP connection is required for the PLC.

teltec systems ag January 20, 2022
Know-How

FOBA Case Study: Laser marking of dental products

You would like to learn how it's possible to create high-contrast, resilient and durable markings on dental products? Then download FOBA's application case study here.

eConsulting Sp. z o. o. October 21, 2021
Video

How can you adapt to the changes in MDR?

In this presentation from Michał Timler, Validation Business Unit Director at eConsulting, you will hear about the preparation of a Transition Plan and you will be provided with the 12 major steps to be ready for new MDR regulations.

ProductLife Group October 7, 2021
Video

Medtech innovations & new regulatory challenges

Full product lifecycle support from Design to Post Market Medical Devices, Combined Devices, SAMDs. How to support new regulatory challenges with planning of smooth transitions. Paolo Guerra, Medtech Lead at ProductLife Group explains more in his keynote.

TS Quality & Engineering September 9, 2021
Showcase

Start creating your MDR Transition Plan

The website eu-mdr.eu is intended to help companies from different sectors and with different products to reach the safe haven of MDR conformity in an efficient way.

CLINICAL CONSULTING sp. z o.o. September 2, 2021
Product Highlight

Regulatory submissions

Clinical Consulting provides transparent regulatory services for pharmaceuticals and medical devices: Regulatory Services - Regulatory Strategy & Development Planning - Competent Authority and Ethic Committee submissions and communication - Regulatory/ GMP Compliance.

ProductLife Group August 17, 2021
Service Highlight

Quality and regulatory services for medical devices

ProductLife Group provides full product lifecycle support from Design to Post Market, and for all domains of Medical Devices, Combined Devices, SAMDs.

ProductLife Group August 17, 2021
Showcase

Auto Injector

PLG supported the registration of the Medical Device within Europe with all connections (Competence Delivery). Draft of the Technical File and ISO 13485 certification, could need an alignment (GAP Analysis) Easy delivery. Surveillance services for Medical Devices (PMS, PSUR, etc.)

PHOTON ENERGY GmbH August 10, 2021
Showcase

Dark marking PERMAblack

A rich blackening of the surface of metals using the CEPHEUS ultrashort pulse laser and our unique PERMAblack process. The markings created with this laser appear deep black and that, unlike annealing colors, regardless of the viewing angle.

PHOTON ENERGY GmbH August 10, 2021
Product Highlight

WORKSTATION with marker CEPHEUS

The WORKSTATION laser system from PHOTON ENERGY GmbH impresses with its individual application options and user-friendliness as an ideal tool for UDI- and MDR-compliant product marking in medical technology.

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