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Eurofins Product Service GmbH Eurofins Electrical & Electronics

Storkower Str. 38 C, 15526 Reichenwalde
Deutschland
Telefon +49 33631 888-801
Fax +49 33631 888-650
reichenwalde@eurofins.de

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Hallenplan

MEDICA 2021 Hallenplan (Halle 9): Stand A34

Geländeplan

MEDICA 2021 Geländeplan: Halle 9

Ansprechpartner

Dr.-Ing. Peter Diesing

Eurofins E&E Germany
Head of Medical Certification

Deutschland

Sanna Jakonen

Eurofins E&E Finland
Manager Medical Devices

Finnland

Holger Hoffmann

Eurofins E&E Switzerland
Sales

Schweiz

Stephanie Baldow

Eurofins E&E Germany
Customer Service Manager

Deutschland

Petri Aho

Eurofins E&E Finland
Business Unit Manager

Finnland

Paolo Dentis

Eurofins E&E Italy
Medical & Personal Device Certification & Laboratory Manager

Italien

Sabine Schleusener

Eurofins E&E Germany
Marketing

Deutschland

Philippe Sissoko

Eurofins E&E France
Managing Director

Frankreich

Enrico Caruso

Eurofins E&E Switzerland
Head of Sales & Marketing

Schweiz

Robert Meyer

Eurofins E&E Germany
Customer Service Manager

Deutschland

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Willkommen zum Matchmaking. Möchten Sie mit in Kontakt treten?

Besuchen Sie uns!

Halle 9 / A34

16 Nov 2021

Thema

11:00 - 12:00

Webinar | Testing in accordance with IEC 60601-1 – A rationale to choose the correct standard and an action plan to manage the test project


Inhaltsübersicht:
- When is testing according to the IEC standards family 60601 necessary?
- Which standard(s) must be taken into account in the development and creation of the technical documentation?
- What is the procedure for a standard test and how do I incorporate the results into the technical documentation?

Information and Anmeldung: https://www.eurofins.de/electrical-and-electronics/media-center/webinare/webinare-medizinprodukte

Hinweis: Das Webinar findet in Englischer Sprache statt. 

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17 Nov 2021

Thema

11:00 - 12:00

Webinar | Standards for Medical Devices - How to choose, read and interpret standards in the field of medical devices


Inhaltsübersicht: 
- What are the parts of a standard and how mandatory are they to be understood?
- How do I familiarise myself with a new/unknown standard?
- How should I deal with the reference standards mentioned in a standard?

Information and Anmeldung: https://www.eurofins.de/electrical-and-electronics/media-center/webinare/webinare-medizinprodukte

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Unser Angebot

Produktkategorien

Unsere Produkte

Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Testing | Product Safety Testing

  • Safety testing for active medical devices based on the international IEC 60601*1 standards family including, but not limited to
  • IEC 60601-1:2005+AMD1:2012+AMD2:2020
  • EN 60601-1:2006 + A1:2013
  • AAMI ES 60601-1:2005/(R)2012 + A1:2012
  • CAN/CSA C22.2 No. 60601-1:14
  • Safety testing for in vitro diagnostic medical devices to IEC 61010-2-101 and UL/CAN CSA 22.2 No. 61010-2-101
  • IEC 62133/UL 1642 safety testing of Lithium-Ion Batteries and UL 2054 safety of household and commercial batteries
  • ANSI ISO 14708-3: 2017 for active implantable neurostimulators

Mehr Weniger

Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Testing | CB Scheme

Our Certification Bodies in Germany, Switzerland and the United States are National Certification Bodies (NCB) and the test laboratories are Certification Body Testing Laboratories (CBTL) under the international certification body scheme (CB Scheme).

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Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Testing | Radio/Wireless Testing

  • WLAN, Bluetooth, ZigBee, GSM/GPRS, UMTS, Wireless Power Transfer (WPT), and LTE
  • Ultra-low power active medical  implants (ULP- AMI)
  • Medical device RFID susceptibility testing
  • Medical device wireless coexistence testing

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Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Testing | Reliability Testing

Corrosion tests, IP tests, temperature shock, overpressure, temperature and altitude, faster decompression, shock and vibration etc.

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Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Testing | Performance Testing

Functionality, energy efficiency, durability and reliability, performance claims validation

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Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Testing | Other related testing services

  • Digital Testing Services (software, functionality, interoperability)
  • Cybersecurity testing
  • Biocompatibility testing according to the ISO 10993 standards family and microbiological studies (GLP)
  • Chemical characterisation for materials, extractable and leachable substances evaluation
  • Medical device packaging testing with distribution simulation testing, fragility, shock compression testing

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Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Certification | Notified Body Services for the EU

In Europe, the use of a Notified Body (NB) is required in the approval or certification process for medical devices. To assist you in placing your medical devices onto the EU market, Eurofins E&E has a number of Notified Bodies (NB) who can provide conformity assessment to:
• Medical Device Regulation 2017/745
• Medical Device Directive 93/42/EEC
• IVD Directive 98/79/EC

Mehr Weniger

Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Medical Device Certification | North American Services

For the North American markets, an NRTL mark demonstrates compliance with the required standards for workplace safety which include hospitals, clinics, therapy centres and similar facilities.

Eurofins E&E North America is both an NRTL recognised by OSHA and an SCC Certification Body and can provide the MET NRTL mark to demonstrate compliance with the requirements of both of these bodies for medical devices.

The Eurofins MET-certified products certification mark is universally accepted in both the US and Canada for medical equipment.

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Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Quality Management Systems & Audits | ISO 13485 Quality Management System (QMS)

The global standard ISO 13485 stipulates the quality management requirements for regulatory purposes for medical device manufacturers and is the certified quality management system that is most broadly recognised in the medical sector.

Eurofins E&E has three ISO 13485 QMS Certification Bodies to assist in your compliance process:
• Finland: Eurofins Expert Services, No. S021
• Germany: Eurofins Product Service GmbH, D- ZM-12092-01-00
• Italy: Eurofins Product Testing Italy s.r.l., No. 133A

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Produktkategorie: Technisches Gerätemanagement, Prüfdienste / Zertifizierungsstellen, Zertifizierung und Prüfung medizinischer Geräte, Qualitätssicherung

Quality Management Systems & Audits | Medical Device Single Audit Program (MDSAP)

Our certification body in Finland acts in cooperation with an MDSAP recognised auditing organization, DQS Medizinprodukte GmbH, and can provide your organisation with MDSAP certification.
Please note that this service is only available in conjunction with the Notified Body services provided by Eurofins Expert Services in Finland (NB No. 0537).

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Über uns

Firmenporträt

Eurofins E&E offers a range of testing and certifications services to help you get your medical devices to market on-time and on budget. Our international network of accredited electrical and electronics (E&E) laboratories and certification bodies offer a comprehensive range of testing and certification services for active and non-active medical devices and In Vitro Diagnostic Medical Devices (IVDs). Our experience and expertise provide you with the confidence to design, develop and deliver tested and certified products to your chosen markets, efficiently and cost-effectively.


Meet the demands of global markets

The market for medical devices is global and in all important markets, regulatory requirements are in place to ensure that products meet the highest standards and that they do not present a risk to patients or users alike. Unfortunately, these regulatory requirements and the methods of approval differ between countries and only in a few cases are these mutually recognised. For example, products must comply with EU Directives in the European Economic Area, the FDA's requirements in the United States, Health Canada's requirements in Canada, JPAL regulations in Japan and TGA requirements in Australia. In addition to these markets, many important countries globally have their own regulatory systems for medical devices and managing these requirements complex and time-consuming. Eurofins E&E provides you with a single point of contact for the testing and certification of your medical devices, allowing you to access your chosen markets, quickly, easily and cost- effectively.


Conformity assessment for EU markets

Our network of accredited laboratories and certification bodies offer a comprehensive range of testing and certification services for both active and non-active medical devices and in vitro diagnostic medical devices in line with the requirements of the MDD (medical device directive), MDR (medical device regulation) and the IVDD (in vitro diagnostic devices directive) for EU markets.
To assist you in placing your medical devices onto the EU market, Eurofins E&E has a number of Notified Bodies (NB) who can provide conformity assessment to:
• Medical Device Regulation 2017/745
• Medical Device Directive 93/42/EEC
• IVD Directive 98/79/EC


Certification for the US & Canada

To access the United States (US) and Canadian markets, medical devices or equipment needs to be certified. For the US, this should be undertaken by a Nationally Recognised Testing Laboratory (NRTL) and for Canada, a Standards Council of Canadian (SCC) Certification Body. Eurofins E&E North America is both an NRTL recognised by OSHA and a Certification Body accredited by the SCC and can provide the MET NRTL mark to demonstrate compliance with these requirements.

Unternehmensdaten

Geschäftsfelder
  • Bildgebung und Diagnostik / Medizinische Ausrüstung und Geräte
  • Laborausstattung
  • Diagnostika
  • Physiotherapie / Orthopädietechnik
  • Medizinische Dienstleistungen und Verlagserzeugnisse