SGS Group of München at MEDICA 2020 in Düsseldorf -- COMPAMED Trade Fair
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SGS Group

Hofmannstr. 50, 81379 München
Germany
Telephone +49 89 787475-133
Fax +49 89 12504064-133
de.medical@sgs.com

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Contact

Susanna Serra

Global Manager
CRS EE Medical Devices

BARCELONA, Spain

Phone
+34 628 311 795

Email
Susanna.serra@sgs.com

Armin Hudetz

Division Manager EMC & Product Safety
EMC & Product Safety

München, Germany

Phone
+49 173 372 93 53

Email
armin.hudetz@sgs.com

Andreas Michel

Business Development Manager Medical Devices
Medical Product Safety

München, Germany

Phone
+49 89 787 475 - 425

Email
andreas.michel@sgs.com

Jan Huber

Business Development Manager EMC & Product Safety
EMC & Product Safety

München, Germany

Phone
+49 (0) 89 787 475 443

Email
jan.huber@sgs.com

Malika Moukaideche

SGS Medical Devices Sales Manager

France

Phone
+33 6 20 09 88 14

Email
Malika.Moukaideche@sgs.com

Souheil Mansour

Medical Devices Strategic Expert
Medical Devices

Aix en Provence, France

Phone
+33 6 20 09 84 24

Email
souheil.mansour@sgs.com

Calogero Lana

Business Unit Manager
Division SGS CEBEC

Brussels, Belgium

Phone
+32.2.556.00.55

Email
calogero.lana@sgs.com

Seppo Vahasalo

NB MDD 0598 Manager
Medical Devices

Helsinki, Finland

Phone
+358 40 560 9500

Email
Seppo.Vahasalo@sgs.com

Kati Lisitsin

Account Manager

Helsinki, Finland

Phone
+358 43 827 3155

Email
kati.lisitsin@sgs.com

Gudrun Neumann

Team Leader Software
Functional Safety

München, Germany

Phone
+49 89 78 74 75 216

Email
Gudrun.neumann@sgs.com

Jacques Kruse Brandao

Global Head of Advocacy
DIGITAL TRUST SERVICES

Hamburg, Germany

Phone
+49 170 9209055

Email
jacques.kruse-brandao@sgs.com

Thomas Röder

Head of Marketing & Sales, Secure Products & Systems
Cybersecurity Services

Graz, Austria

Phone
+43 664 88210582

Email
Thomas.Roeder@sgs.com

David Schramm

Operations Manager

Suwanee, GA, USA

Phone
+1 678 822 2981

Email
david.schramm@sgs.com

Robert Burek

Global Medical Device Technical Manager

Suwanee, GA, USA

Phone
+1 404-275-1134

Email
Robert.Burek@sgs.com

Artem Sher

Sr. Account Executive
Consumer and Retail, Electrical and Electronics

USA

Phone
+1 (201) 587-6377

Email
Artem.Sher@sgs.com

Kerry Strain

SALES EXECUTIVE

USA

Phone
+1 973-575-5252

Email
Kerry.Strain@sgs.com

Gavin-Y Yin

Manager Medical Devices
Medical Electrical Devices Lab

Shanghai, China

Phone
+86 (0) 21-61915607

Email
gavin-y_yin@sgs.com

Jason Hoo

MED Lab Manager

Guangzhou, China

Phone
+86 (20) 82155370

Email
Jason.Hoo@sgs.com

Andréa Souza

MED - Team leader

Brazil

Phone
+ 55 11 95654 2080

Email
andrea.desouza.external@sgs.com

Allan Andrade

Technical Manager

Brazil

Phone
+55 11 94244 4817

Email
allan.andrade@sgs.com

Luiz Ferri

SBU Manager

Brazil

Phone
+55 11 9 5659 0351

Felippe Ramos

Sales Executive

Brazil

Phone
+55 11 95658-0483

Email
felippe.ramos@sgs.com

Gloria Herranz

Spain

Phone
+34 608 27 1570

Email
gloria.herranzsanz@sgs.com

Daniel Arranz

Spain

Phone
+34 669 16 8000

Email
daniel.arranzmuniz@sgs.com

Joseph Shen

Lab Manager Product Safety

New Taipei City, Taiwan

Phone
+886 (02) 2299-3939

Email
Joseph.Shen@sgs.com

Roger Liu

New Taipei City, Taiwan

Phone
+886 (02) 2299-3939

Email
Roger-tw.Liu@sgs.com

Johan Goris

Project Leader Medical & Health Products

Brussels, Belgium

Phone
+32. 484 81 13 53

Email
johan.goris@sgs.com

Bernd Auer

Head of Business Development DACH & Nordics
SGS DIGITAL TRUST SERVICES

Germany

Phone
+49 (0)173 6733811

Email
bernd.auer@sgs.com

Romy Petters

Product Manager Materials and Surface

Dresden, Germany

Phone
+49 351 8841 150

Email
Romy.Petters@sgs.com

Petra Müller

Customer Service Manager Special Analytics

Dresden, Germany

Phone
0049 351 8841-155

Email
Petra.Mueller@sgs.com

Our range of products

Product categories

  • 07  Medical services and publications
  • 07.04  Education

Our products

Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS Global Medical Device Testing and Certification Services

In the electro-medical devices sector, trusted suppliers and partners are key to reaching your target markets. We have the specialized industry knowledge and market experience to help you stay on top of regulatory requirements around the world. With our customizable test and audit packages, you can ensure compliance with the requirements of multiple target markets at the same time.

Our electro-medical service portfolio includes:

Testing
For all EU and International Product Safety Regulations, US NRTL, Standard council of Canada, EMC (IEC/EN 60601-1-2, and IEC/EN 61326 series including CB), functional safety, wireless devices, rechargeable batteries, restricted substances, packaging and the product safety of medical diagnostic x-ray devices.

Pre-testing
During the product development phase with screening of risk management, software life cycle and usability activities.

Certification
Against all relevant ISO standards – 13485, 9001 and 14001, the major EU Medical Directives – 93/42/EEC and 98/79/EC, as well as other EC directives, US 510(k) Support Services, US FDA Site Inspections, JPAL and others.

Training
For medical device regulations, standards and testing practices.

Other services
Like biocompatibility evaluation, audits, clinical trials, hygienic qualification, microbiological tests of products, product control for possible toxic residues and failure analysis for root cause clarification of malfunction on all kind of active and passive medical devices.

Our global network of experts and testing labs allows you to access the entire range of trusted SGS services in your manufacturing region and close to all major medical markets, at all times.

Regardless of the project size and number of markets targeted, we can improve the efficiency and value of your operation by combining the advantages of our worldwide reach, the wide range of accreditations, resources and global expertise into one global package.

We can support you in testing for the various medical product categories, e.g.:
Ventilator,
Patient monitors,
HF surgical equipment,
Clinical thermometers,
Infusion pumps,
Heart-lung support
X-Ray diagnostics
We are accredited to test active medical devices for the following use scenarios:
Professional clinical environment
Home-health-care environment
Road ambulance (IEC 60601-1-12, EN 1789)
Air borne (IEC 60601-1-12, RTCA DO-160G)

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS US / Canada Certification

SGS North America is officially recognized by the Occupational Safety and Health Administration (OSHA), as a Nationally
Recognized Testing Laboratory (NRTL) in the US and accredited by the Standards Council of Canada (SCC) in Canada.
For products outside the workplace, SGS is separately accredited to certify products under ISO Guide 65/17065.
The SGS certification mark is widely accepted in throughout the US and Canada.

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS INMETRO - Meet regulatory requirements for electro-medical devices in Brazil

Medical devices intended for sale in Brazil must be prior approved by the country’s National Health Surveillance Agency (ANVISA). Accredited by CGCRE – General Coordination for Accreditation of INMETRO as a certification body, SGS supports medical device manufacturers bringing products to market.

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

Cyber Threats in Healthcare and ways to respond - SGS Cybersecurity Services Services for Medtech Products

Medical systems and devices have become more and more connected and interoperable. Simplified patient and patient-data-management, real time availability of diagnostic data across hospital networks, and new remote monitoring features are significantly increasing effectiveness and efficiency in healthcare. The advantages provided are many. However, connected MedTech products and systems are prone to cyber security threats.

In fact, medical systems and hospital networks have become one of the most attractive targets for hackers. Why? One reason is that the data in the systems is very valuable. Medical records can be stolen and sold; social security numbers and respective identities can be misused to generate financial gain. Hospital networks are part of critical infrastructure. Availability and performance of such systems is key, making equipment attractive to digitally hold for ransom.

Unnoticed digital manipulation of products and systems can lead to fatal situations. Security researchers have shown several times how to hack pacemakers or insulin pumps. The WannaCry worm incident in 2017 was an eye opener. In the United Kingdom, NHS stroke centers had to close, surgeries had to be postponed. Thousands of patients were heavily affected. The threats are real, and actions have to be taken.

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS RoHS Testing for Medical Devices

European Union Directive 2011/65/EU, also known as RoHS II (2011/65/EU) updated legislation governing the Restriction of Hazardous Substances in electrical and electronic equipment, extending its scope to include medical devices already in 2014.

Independent and innovative, our Electrical & Electronics experts use state-of-the-art facilities and technology to deliver tailor made added value services that help improve your business. With more than 90 years experience we have a deep understanding of hazardous substances and we operate more than 28 accredited RoHS testing centres worldwide, staffed by more than 1,000 RoHS specialists.

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS Ventilator & Thermometer TESTING & CERTIFICATION SERVICES

We have a global network of established medical devices laboratories with 98 electro-medical categories. Click on the brochure below, to find out, what we can do for Ventilator & Thermometer Manufacturers

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS safety and performance testing for Face masks and N95 respirators (ASTM D2299, ASTM F2100, ASTM D2101, EN 14683, ASTM F1862, ASTM D2905

SUB-MICRON PARTICULATE FILTRATION EFFICIENCY (PFE) – ASTM D2299
BACTERIAL FILTRATION EFFICIENCY (BFE) – ASTM D2101
BREATHABILITY – EN 14683
FLUID RESISTANCE – ASTM F1862
PUNCTURE RESISTANCE – ASTM D2905
ASTM F2100 MEDICAL MASK RATINGS
N95 RESPIRATORS

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS Safety and Performance Testing on Face Masks IN EUROPE (EN 14683, FFP2/FFP3, ISO 22609, ISO 9237)

Traditionally, masks have fallen into two categories – medical face masks (such as surgical masks), which fall under the medical
device regulations, and protective masks (such as particle filtering half masks) that are applicable to personal protective equipment (PPE) regulations. Given the COVID-19 pandemic, a third category of mask is emerging.

A reusable face mask, also referred to as a “barrier mask” or “community face covering”, is designed specifically as a means to
control the spread of COVID-19. Neither a medical device nor recognized as PPE, these reusable masks have recently been classified into their own group and been determined the requirements that they should meet.
EN 14683 is the
primary EU standard for medical face masks. Within the standard there are three types of masks: Type I with Bacterial Filtration
Efficiency (BFE) > 95% mainly for patient use, type II with BFE > 98% and Type IIR with splash resistance.
For the re-usable fabric masks there is CEN guidance: CWA 17553:2020 Community face coverings - Guide to minimum
requirements, methods of testing and use, that covers the planning, manufacturing and testing of the masks. The guidance
includes also materials, washing and required instructions for use.
  • SUB-MICRON PARTICULATE FILTRATION EFFICIENCY (PFE)
  • BREATHABILITY – EN 14683 ANNEX C
  • BACTERIAL FILTRATION EFFICIENCY (BFE) – EN 14683 ANNEX B
  • SPLASH RESISTANCE – ISO 22609
  • PERFORMANCE REQUIREMENTS FOR MEDICAL FACE MASKS (TYPE I a TYPE II TYPE IIR)
  • Particle filtering half masks (FFP2/FFP3) according EN 149. Category lll equipment as per the Regulation (EU) 2016/425 personal protective equipment (the PPE regulation). PENETRATION OF FILTER MATERIAL; BREATHING RESISTANCE
  • REUSABLE FABRIC MASKS: FILTRATION – PFE AND BFE; FILTRATION - DGA ANNEX 2 HOLI POWDER; BREATHABILITY - ISO 9237; FLANGE GAME RESISTANCE TEST

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS Disposable Medical PPE testing services

No matter if you are a manufacturer or retailer for medical masks, gowns or gloves. Testing is important to ensure their safety and usability. Our global medical PPE technical committee with members from all around the world, like the US, Finland, China and UK. We will help you that global requirements won’t be an obstacle to you. 

Respirators
  • US: NIOSH (e.g. N95)
  • EU: EN 149 (e.g. FFP3)
  • China: GB 2626 (e.g. KN 95)
Medical Masks
  • US: ASTM F2100
  • EU: EN 14683
  • China:  YY/T 0469-2011: Surgical Masks and  YY/T 0969-2013: Single-Use Medical Face Mask
Gowns
  • US/CANADA: CSA Z314, AAMI Barrier
  • Performance, ASTM F2407 (surgical) and ASTM
  • F3352 (isolation)
  • EU: EN 14126
  • CHINA: GB 19082
Gloves
  • US/CANADA: ASTM D3577 (surgical), ASTM
  • D3578/D6319 (examination)
  • EU: EN 455 (medical)
  • CHINA: GB 7543, GB 24786, GB 24787 (surgical)
General
  • Microbial Cleanliness
  • Sterility Assurance Level
  • Biocompatibility

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS Product safety testing for medical diagnostic x-ray manufacturers

SGS services for medical diagnostic x-ray devices deliver solutions for all market players, from small companies
working in a specific niche, to large global manufacturers.

With a global network of x-ray experts we have qualified personnel located near your facility and can conduct the required testing on your premises. Our global presence is your advantage.

Examples for International standards covered by the SGS service
  • IEC 60601-1 general requirements
  • IEC 60601-1-3 radiation protection
  • IEC 60601-1-6 usability
  • IEC 60601-1-8 alarm systems
  • IEC 60601-2-28 X-ray tube assemblies
  • IEC 60601-2-43 X-ray equipment for interventional procedures
  • IEC 60601-2-44 computed tomography
  • IEC 60601-2-45 mammography
  • IEC 60601-2-54 radiography
  • IEC 60601-2-63 dental extra-oral X-ray equipment
  • IEC 60601-2-65 dental intra-oral X-ray equipment

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Product category: Reports and analyses, Education, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS at the virtual Medica 2020 - overview Video

SGS at the virtual Medica 2020 - check out our overview Video

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS material- & failure analysis for medical devices

Control and quality assurance in the field of medical devices is crucial. A broad spectrum of analytical methods is available at SGS INSTITUTE FRESENIUS, Dresden site. Chemical analysis, as well as material and surface analyses, are available from one source. The interdisciplinary cooperation of experienced chemists, physicists, and material scientists provides you with the best possible results and findings.

In the field of material and surface analysis (cleanliness), analysis of functional layers as well as primary and secondary packaging of medical devices, we offer a comprehensive portfolio and know-how for testing and ensuring the quality and performance requirements of your products.

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Product category: Reports and analyses, Technical equipment management, test houses / certification bodies, Certification and testing of medical devices, quality assurance

SGS particle and cleanliness analysis for medical devices

The surface cleanliness of medical devices is an essential quality feature in the complete processing and value chain. In addition to sterility, the physical and chemical surface properties and cleanliness are also important, especially for implants and for products with patient or drug contact. The impurities on the product surface can be particles, films/layers, deposits, or a combination of these.

SGS offers for all kinds of contaminations the appropriate investigation method, which allows the identification, the detailed qualification and/or quantification as well as a substance group screening.

Furthermore, we would be pleased to support you in the analysis of particle contaminations or deposit- or layer-forming substances, which can occur due to corrosion, condensation, sedimentation, absorption, abrasion, or simply due to cleaning residues. In addition to routine analyses, we also undertake complex project-related and problem-oriented investigations.

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Company news

Date

Topic

Download

Nov 16, 2020

Current Regulation and overview - INMETRO SGS Certification process for Brazilian Market Medical Devices

MEDICAL DEVICES – CERTIFICATION PROCESS
Brazilian Market – INMETRO
An Overview and the better solutions for INMETRO certification process

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About us

Company details

SGS is the world’s leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 89,000 employees, we operate a network of more than 2,600 offices and laboratories around the world.

Our core services can be divided into four categories:

Inspection: our comprehensive range of world-leading inspection and verification services, such as checking the condition and weight of traded goods at transshipment, help you to control quantity and quality, and meet all relevant regulatory requirements across different regions and markets
Testing: our global network of testing facilities, staffed by knowledgeable and experienced personnel, enable you to reduce risks, shorten time to market and test the quality, safety and performance of your products against relevant health, safety and regulatory standards
Certification: we enable you to demonstrate that your products, processes, systems or services are compliant with either national or international standards and regulations or customer defined standards, through certification
Verification: we ensure that products and services comply with global standards and local regulations. Combining global coverage with local knowledge, unrivalled experience and expertise in virtually every industry, SGS covers the entire supply chain from raw materials to final consumption.

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Company data

Sales volume

> 500 Mio US $

Number of employees

> 5000

Foundation

1878