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)

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.

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.

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.

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.

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.

Swiss Medtech Expo 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.

Swiss Medtech Expo 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.

Swiss Medtech Expo 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.)

Swiss Medtech Expo 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.

Swiss Medtech Expo 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.

Swiss Medtech Expo 2021

Events (9)

MedtecLIVE & SUMMIT 2021

Event Apr 20, 2021 9:45 AM - Apr 22, 2021 5:00 PM

Join us at the virtual MedtecLIVE & SUMMIT 2021 to see the current and future developments and innovations in the medical technology industry. Experience the progress in the MedTech sector live. There are many good reasons to mark 20 to 22 April, 2021 in your calendar.

Webinar Series: MDR Readiness Q&A

Event Dec 18, 2020 4:30 PM - 5:30 PM

In less than six months – on 26 May 2021 – the Medical Devices Regulation (MDR) and the corresponding Swiss Medical Devices Ordinance (MedDO) will come into force. In our role as an industry association, we wish to provide advice and support with the webinar series titled «MDR Readiness Q&A».

Webinar series MDR@noon

Event Oct 14, 2020 12:00 PM - 1:00 PM

The webinar series MDR@noon offers all interested parties an insight into the relevant regulatory issues for the medical device industry. The entire event will be held in English and is free of charge. It starts at noon and finishes at 13.00 h.

What you need to know about UDI marking

Event May 7, 2020 5:00 PM - 6:00 PM

With the UDI system (Unique Device Identification) manufacturers are obliged to identify and register medical devices. In this webinar, laser marking experts will tell you what you need to know about UDI marking of medical devices, instruments and implants.

Neue Wege für KMU und Start-ups beim Marktzugang

Event Sep 10, 2019 10:04 AM - 10:27 AM

Oft fehlt das nötige Wissen, um im stark regulierten Markt der Medizinprodukte auf den Markt zu gelangen. Zulassungsfragen werden dabei zu einem wichtigen strategischen Faktor. In diesem Referat geht es um die vereinfachte und beschleunigte Zulassung von Medizinprodukten.

Innovation Symposium: The new MDR & IVDR

Event Sep 10, 2019 9:15 AM - 11:30 AM

Given the breadth of new regulations, medical device manufacturers now need a plan to ensure that deadlines are met. The Innovation Symposium at Swiss Medtech Expo in Lucerne is where experts will present the key to successfully mastering the new MDR & IVDR.

Providers (22)

Health Tech Cluster Switzerland

HTCS provides a network for companies, universities, research institutions and investors. HTCS is personalized - immediate - individual.

Schwyz, 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 regulatory requirements a comprehensive range of training and education

Olten, Switzerland

konplan

konplan focuses on competitive advantage through innovative and individual technical solutions. The competent team of engineers and project managers meets your challenges in all phases of the development process.

Rotkreuz, 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 positioning systems manual and motorized, ISEL - CNC machines, Automation, aluminum profiles,

Bremgarten, Switzerland

Siemens Digital Industries Software

We offer digitalization solutions for companies in the medical device industry. Our proven, flexible solutions help speed up innovation in medical device development, ensure quality, reduce costs and maintain adherence to ever-changing global regulations, including MDR and FDA compliance.

51063 Köln, Germany

TS Quality & Engineering

TS Quality & Engineering is a ISO 13485 certified company. We offer Medical Device Consulting Services and solutions aimed at facilitating, speeding up and support design, validation, regulatory and quality control process. We can follow the design and development of a new product at all stages.

Riccione, Italy

RMS Foundation

The RMS Foundation is an independent service laboratory and research institute. The range of services offered by this non-profit organization includes material testing, advisory services, training as well as technology transfer.

Bettlach, Switzerland

Aligned AG

Spending too much time on design documentation and traceability? We can help! Develop medical devices smarter and faster with Aligned Elements.

Zürich, Switzerland

epmodex GmbH

We are your leading partner for development, manufacturing and registration of medical and industrial products in high-end applications. Whether prototypes or finished products in small- and large series: epmodex stands for highest precision, optimal solutions and a reliable partnership.

Dübendorf, Switzerland