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).
22. July 2021
Discover in our white paper 6 good reasons why outsourcing is even more worthwhile for medical device manufacturers during these times of the new medical device regulation (MDR).
Since May 26th 2021, the Medical Device Regulation is fully applicable. Hence, all processes related to design, industrialization, manufacturing, marketing and market surveillance have to be aligned with the quality management system which must be compatible with ISO 13485:2016 and/or USA QSR.
20. July 2021
With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.
28. June 2021
On May 26, 2021, the Medical Device Ordinance came into force. All EU manufacturers therefore have to comply with specific Swiss requirements per MedDO and the appointment of a Swiss-AR for all medical devices imported into Switzerland. As your new Swiss-AR epmodex will support you.
8. April 2021
The virtual MedtecLIVE & SUMMIT is the leading gathering of the European medical technology community in the first half of the year. The event will take place from 20 to 22 April, a good month before the European Medical Device Regulation (MDR) becomes binding on 26 May 2021.
13. January 2021
Many medical devices consist of several components and are exposed to cyclical loads during use. Resulting micromovements can generate abrasion particles. To prove the safety of a product, it is often necessary to determine the type, quantity and size of the wear particles.
4. November 2020
The laws, regulations and standards hang like a sword of Damocles over the heads of medtech companies, especially medtech start-ups. The topic of "overregulation" seems to have become a daily mantra. But do regulations really slow down innovation?
19. August 2020
The quality and safety requirements for medical devices are becoming increasingly stringent. For this reason, the cleanliness of medical devices is being examined more closely.
11. August 2020
Traceability is at the heart of quality assurance and is the basis of risk management for medical devices. Read this whitepaper to learn how you can significantly improve the process.
10. December 2019
Manufacturers of medical devices are subject to a growing number of regulations that require more documentation. Learn from Karl Larsson, Managing Director Aligned AG, how Tecan dramatically reduced its effort with a modular documentation approach.
26. August 2019
The MDR in combination with ISO 13485:2016 implies an "end-to-end" surveillance along the entire value chain. KH Medical illustrates a way how to implement these new requirements in four steps.
8. August 2019
To continue offering his products on the market, a customer had to check the documentation of existing product lines and adapt it to current regulations. With the support of EXCO, he was able to close the gaps in the shortest possible time and pass the subsequent TÜV audit.
We offer solutions for the regulated market. EXCO examines your processes and documentation for compliance with the requirements of the new EU MDR / IVDR. This includes individual consultation with recommendations for action and the specific implementation of entire work packages.
30. July 2019
The new EU Medical Devices Directive (MDR) affects everyone and there are only a few months left before important transition periods for the certification of medical devices expire for manufacturers. This showcase shows you how to successfully implement MDR in simple steps.
8. July 2019
UDI-marking with laser technology: FOBA's White paper provides you with all the information about the requirements, deadlines, secure labeling
according to FDA (USA) and MDR (Europe)
3. July 2019
Like all medical device manufacturers, Tecan is subject to a growing number of regulations. Learn how Tecan reduced its effort by up to 80 % with a modular documentation approach.
21. June 2019
Severe criticism against manufacturers of medical devices and related supervision processes occurred in November 2018 and questioned the reliability of implants. In this context, FOBA considers UDI-codes, firmly applied on medical implants, to be a key-factor for safe traceability of implants.
19. June 2019
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 which changes you will have to make and what needs to be taken into account.
18. June 2019
The MDR presents new challenges to medical device manufacturers: How should they map PMS? Which solutions support risk management? With Teamcenter, the PLM system that connects people and processes, the medical device manufacturer Julius Zorn has found a solution.
3. June 2019
Teamcenter is one of the most widely used technologies for Digital Product Lifecycle Management. The specialized "Medical Device Solution" module for Teamcenter simplifies collaboration and digital communication between technical, commercial and creative departments.
The need for marking of medical devices leads to questions about their resistance. For a manufacturer of orthopaedic implants, RMS tested the corrosion resistance of laser markings with the EC-Pen, which enabled the resistance of medical products to be specifically optimized.
4. April 2019
The Innovation and Research Center (IFC) Tuttlingen of the Hochschule Furtwangen University of Applied Sciences (HFU) and FOBA Laser Marking + Engraving have officially launched their innovation cooperation for medical technology. A modern laser marking system is now available for research and demo.
RUDOLF Medical GmbH was on the lookout for the most suitable technology in the course of the dispute with the UDI regulations. In this example, you will learn which solution the company is using to set the laser as the standard of the future and is optimally positioned for UDI and MDR.
14. February 2019
9. January 2019
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 machines. Our laser marking machines adapt with various lasers and powers (fiber- or UV-lasers).
19. November 2018
12. July 2018
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 your company. The training provides a brief and practical introduction to the new regulatory requirements for the medical device industry.
Medical imaging, emergency care, surgical systems: As reliable OEM solution partner, we create your medical devices – from idea to fabrication.
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.
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.
MedtecLIVE together with the MedtecSUMMIT Congress is a leading networking platform for the medical technology sector. The 2nd virtual edition takes place from 20 to 22 April 2021. www.medteclive.com
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.
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.
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.
Swiss Medtech Expo is the trade fair for Europe's third-largest medtech market. With a practical focus on novel designs, materials, technologies and processes, the spotlight is on how integration and development of new applications leads to innovations in the medtech industry.
With five facilities on three continents, KH is positioned optimally to serve its customers locally and globally: From manufacturing of high-quality plastic components to the sophisticated assembly of sterile single-use devices in a clean-room.
EXCO is a globally active technology service provider that delivers custom-made project support services from one convenient source. The company's portfolio includes consulting services, project management and the implementation of ready-to-use solutions in product, laboratory and production.
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,
Spending too much time on design documentation and traceability? We can help! Develop medical devices smarter and faster with Aligned Elements.
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
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