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SGS Group
Hofmannstr. 50,
81379
München
Germany
Germany
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Contact
Susanna Serra
Global Manager
CRS EE Medical Devices
CRS EE Medical Devices
Armin Hudetz
Division Manager EMC & Product Safety
EMC & Product Safety
EMC & Product Safety
Andreas Michel
Business Development Manager Medical Devices
Medical Product Safety
Medical Product Safety
Jan Huber
Business Development Manager EMC & Product Safety
EMC & Product Safety
EMC & Product Safety
Malika Moukaideche
SGS Medical Devices Sales Manager
Souheil Mansour
Medical Devices Strategic Expert
Medical Devices
Medical Devices
Calogero Lana
Business Unit Manager
Division SGS CEBEC
Division SGS CEBEC
Seppo Vahasalo
NB MDD 0598 Manager
Medical Devices
Medical Devices
Kati Lisitsin
Account Manager
Gudrun Neumann
Team Leader Software
Functional Safety
Functional Safety
Jacques Kruse Brandao
Global Head of Advocacy
DIGITAL TRUST SERVICES
DIGITAL TRUST SERVICES
Thomas Röder
Head of Marketing & Sales, Secure Products & Systems
Cybersecurity Services
Cybersecurity Services
Robert Burek
Global Medical Device Technical Manager
Artem Sher
Sr. Account Executive
Consumer and Retail, Electrical and Electronics
Consumer and Retail, Electrical and Electronics
Gavin-Y Yin
Manager Medical Devices
Medical Electrical Devices Lab
Medical Electrical Devices Lab
Andréa Souza
MED - Team leader
Luiz Ferri
SBU Manager
Brazil
Phone
+55 11 9 5659 0351
Gloria Herranz
Daniel Arranz
Joseph Shen
Lab Manager Product Safety
Johan Goris
Project Leader Medical & Health Products
Bernd Auer
Head of Business Development DACH & Nordics
SGS DIGITAL TRUST SERVICES
SGS DIGITAL TRUST SERVICES
Romy Petters
Product Manager Materials and Surface
Petra Müller
Customer Service Manager Special Analytics
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Our range of products
Product categories
- 07 Medical services and publications
- 07.01 Reports and analyses
Reports and analyses
- SGS Global Medical Device Testing and Certification Services
- SGS US / Canada Certification
- SGS INMETRO - Meet regulatory requirements for electro-medical devices in Brazil
- Cyber Threats in Healthcare and ways to respond - SGS Cybersecurity Services Services for Medtech Products
- SGS RoHS Testing for Medical Devices
- SGS Ventilator & Thermometer TESTING & CERTIFICATION SERVICES
- SGS safety and performance testing for Face masks and N95 respirators (ASTM D2299, ASTM F2100, ASTM D2101, EN 14683, ASTM F1862, ASTM D2905
- SGS Safety and Performance Testing on Face Masks IN EUROPE (EN 14683, FFP2/FFP3, ISO 22609, ISO 9237)
- SGS Disposable Medical PPE testing services
- SGS Product safety testing for medical diagnostic x-ray manufacturers
- SGS at the virtual Medica 2020 - overview Video
- SGS material- & failure analysis for medical devices
- SGS particle and cleanliness analysis for medical devices
- 07 Medical services and publications
- 07.04 Education
- 07 Medical services and publications
- 07.15 Technical equipment management, test houses / certification bodies
Technical equipment management, test houses / certification bodies
- SGS Global Medical Device Testing and Certification Services
- SGS US / Canada Certification
- SGS INMETRO - Meet regulatory requirements for electro-medical devices in Brazil
- Cyber Threats in Healthcare and ways to respond - SGS Cybersecurity Services Services for Medtech Products
- SGS RoHS Testing for Medical Devices
- SGS Ventilator & Thermometer TESTING & CERTIFICATION SERVICES
- SGS safety and performance testing for Face masks and N95 respirators (ASTM D2299, ASTM F2100, ASTM D2101, EN 14683, ASTM F1862, ASTM D2905
- SGS Safety and Performance Testing on Face Masks IN EUROPE (EN 14683, FFP2/FFP3, ISO 22609, ISO 9237)
- SGS Disposable Medical PPE testing services
- SGS Product safety testing for medical diagnostic x-ray manufacturers
- SGS at the virtual Medica 2020 - overview Video
- SGS material- & failure analysis for medical devices
- SGS particle and cleanliness analysis for medical devices
- 07 Medical services and publications
- 07.16 Certification and testing of medical devices, quality assurance
Certification and testing of medical devices, quality assurance
- SGS Global Medical Device Testing and Certification Services
- SGS US / Canada Certification
- SGS INMETRO - Meet regulatory requirements for electro-medical devices in Brazil
- Cyber Threats in Healthcare and ways to respond - SGS Cybersecurity Services Services for Medtech Products
- SGS RoHS Testing for Medical Devices
- SGS Ventilator & Thermometer TESTING & CERTIFICATION SERVICES
- SGS safety and performance testing for Face masks and N95 respirators (ASTM D2299, ASTM F2100, ASTM D2101, EN 14683, ASTM F1862, ASTM D2905
- SGS Safety and Performance Testing on Face Masks IN EUROPE (EN 14683, FFP2/FFP3, ISO 22609, ISO 9237)
- SGS Disposable Medical PPE testing services
- SGS Product safety testing for medical diagnostic x-ray manufacturers
- SGS at the virtual Medica 2020 - overview Video
- SGS material- & failure analysis for medical devices
- SGS particle and cleanliness analysis for medical devices
Our products
SGS Global Medical Device Testing and Certification Services
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)
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)
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.
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.
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.
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.
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.
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.
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.
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
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
BACTERIAL FILTRATION EFFICIENCY (BFE) – ASTM D2101
BREATHABILITY – EN 14683
FLUID RESISTANCE – ASTM F1862
PUNCTURE RESISTANCE – ASTM D2905
ASTM F2100 MEDICAL MASK RATINGS
N95 RESPIRATORS
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.
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
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
Respirators
- US: NIOSH (e.g. N95)
- EU: EN 149 (e.g. FFP3)
- China: GB 2626 (e.g. KN 95)
- US: ASTM F2100
- EU: EN 14683
- China: YY/T 0469-2011: Surgical Masks and YY/T 0969-2013: Single-Use Medical Face Mask
- US/CANADA: CSA Z314, AAMI Barrier
- Performance, ASTM F2407 (surgical) and ASTM
- F3352 (isolation)
- EU: EN 14126
- CHINA: GB 19082
- US/CANADA: ASTM D3577 (surgical), ASTM
- D3578/D6319 (examination)
- EU: EN 455 (medical)
- CHINA: GB 7543, GB 24786, GB 24787 (surgical)
- Microbial Cleanliness
- Sterility Assurance Level
- Biocompatibility
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
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
SGS at the virtual Medica 2020 - overview Video
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.
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.
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.
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.
Company news
Date
Topic
16 Nov 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
Brazilian Market – INMETRO
An Overview and the better solutions for INMETRO certification process
About us
Company portrait
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.
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.
Company data
Sales volume
> 500 Mio US $
Number of employees
> 5000
Foundation
1878