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Successfully mastering the new MDR & IVDR

Successfully mastering the new MDR & IVDR

Given the breadth of the new regulations, manufacturers need to have a plan in place now in order to ensure compliance by the deadlines. We present keys to successfully mastering the new MDR & IVDR.

Showcases (2)

Laser engraved stainless steel hip ball implant (picture rights: FOBA)

Better Patient Safety due to Laser Marking on Medical Implan

Severe criticism against manufacturers of medical devices and related supervision processes occurred in November 2018 and questioned the reliability…

Published:
14 Feb 2019

We explain everything about the new EU regulations in medical technology!

New Medical Devices Ordinance - What has to be observed?

You are a company in the medtech industry and have been dealing with the new EU regulations for European medical devices for some time? We explain…

Published:
19 Nov 2018

Product highlights (1)

FOBA M-Series Laser Marking Machines

For stand-alone operation in laser class 1, we offer turnkey-ready and custom laser processing machines in the form of manual workstations or special…

Published:
9 Jan 2019

Service highlights (1)

Seminar Medical Device Regulation (EU) 2017/745

Dive into a stress-free world of the new MDR: For all those who want to find out about the new Medical Devices Regulation and its consequences for…

Published:
12 Jul 2018

Providers (3)

konplan systemhaus ag

Die konplan systemhaus ag setzt auf Wettbewerbsvorsprung durch innovative und individuelle technische Lösungen. Das kompetente Team an Ingenieuren…

Rotkreuz

Switzerland

SAQ-QUALICON AG

In the heart of Switzerland, on the pulse of medical technology, we offer specialists as well as generalists in the field of quality management and…

Olten

Switzerland

teltec systems ag

Consulting / Sales / Service of Alltec GmbH - FOBA laser marking machines, Photon Energy - Ultra short pulse laser, OWIS - Optical beam guidance and…

Bremgarten

Switzerland

About the topic

Given the breadth of the new regulations, manufacturers need to have a plan in place now in order to ensure compliance by the deadlines. We present keys to successfully mastering the new MDR & IVDR.