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Eurofins Product Service GmbH Eurofins Electrical & Electronics
Storkower Str. 38 C,
15526
Reichenwalde
Germany
Germany
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Location
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Contact
Dr.-Ing. Peter Diesing
Eurofins E&E Germany
Head of Medical Certification
Head of Medical Certification
Germany
Sanna Jakonen
Eurofins E&E Finland
Manager Medical Devices
Manager Medical Devices
Finland
Holger Hoffmann
Eurofins E&E Switzerland
Sales
Sales
Switzerland
Stephanie Baldow
Eurofins E&E Germany
Customer Service Manager
Customer Service Manager
Germany
Petri Aho
Eurofins E&E Finland
Business Unit Manager
Business Unit Manager
Finland
Paolo Dentis
Eurofins E&E Italy
Medical & Personal Device Certification & Laboratory Manager
Medical & Personal Device Certification & Laboratory Manager
Italy
Sabine Schleusener
Eurofins E&E Germany
Marketing
Marketing
Germany
Philippe Sissoko
Eurofins E&E France
Managing Director
Managing Director
France
Enrico Caruso
Eurofins E&E Switzerland
Head of Sales & Marketing
Head of Sales & Marketing
Switzerland
Robert Meyer
Eurofins E&E Germany
Customer Service Manager
Customer Service Manager
Germany
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Visit us
16 Nov 2021
Topic
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
Topics:
- 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 registration: https://www.eurofins.de/electrical-and-electronics/media-center/webinare/webinare-medizinprodukte
17 Nov 2021
Topic
11:00 - 12:00
Webinar | Standards for Medical Devices - How to choose, read and interpret standards in the field of medical devices
Standards for Medical Devices - How to choose, read and interpret standards in the field of medical devices
Topics:
- 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 registration: https://www.eurofins.de/electrical-and-electronics/media-center/webinare/webinare-medizinprodukte
Topics:
- 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 registration: https://www.eurofins.de/electrical-and-electronics/media-center/webinare/webinare-medizinprodukte
Our range of products
Product categories
- 07 Medical services and publications
- 07.15 Technical equipment management, test houses / certification bodies
Technical equipment management, test houses / certification bodies
- Medical Device Testing | Product Safety Testing
- Medical Device Testing | CB Scheme
- Medical Device Testing | Radio/Wireless Testing
- Medical Device Testing | Reliability Testing
- Medical Device Testing | Performance Testing
- Medical Device Testing | Other related testing services
- Medical Device Certification | Notified Body Services for the EU
- Medical Device Certification | North American Services
- Quality Management Systems & Audits | ISO 13485 Quality Management System (QMS)
- Quality Management Systems & Audits | Medical Device Single Audit Program (MDSAP)
- 07 Medical services and publications
- 07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
- Medical Device Testing | Product Safety Testing
- Medical Device Testing | CB Scheme
- Medical Device Testing | Radio/Wireless Testing
- Medical Device Testing | Reliability Testing
- Medical Device Testing | Performance Testing
- Medical Device Testing | Other related testing services
- Medical Device Certification | Notified Body Services for the EU
- Medical Device Certification | North American Services
- Quality Management Systems & Audits | ISO 13485 Quality Management System (QMS)
- Quality Management Systems & Audits | Medical Device Single Audit Program (MDSAP)
Our products
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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).
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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
• Ultra-low power active medical implants (ULP- AMI)
• Medical device RFID susceptibility testing
• Medical device wireless coexistence testing
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
Medical Device Testing | Reliability Testing
Corrosion tests, IP tests, temperature shock, overpressure, temperature and altitude, faster decompression, shock and vibration etc
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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
• 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
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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.
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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:
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
Product category: Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance
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).
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).
About us
Company portrait
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.
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.
Company data
Area of business
- Imaging and diagnostics / medical equipment and devices
- Laboratory equipment
- Diagnostic tests
- Physiotherapy / orthopaedic technology
- Medical services and publications
