Medical Device Solution

Certificate Verification Service/Test Service/Customized Project/Calibration Service / Training Service
Medical Device Solution

The Benefits Of Choosing SGS: ONE STOP SHOPPING Service

SGS provides professional services to customers throughout the supply chain in the complex medical equipment market to help customers successfully put their products on the market and deliver them to users quickly and accurately. We provide training, testing and verification solutions for manufacturers and their suppliers.

Therefore, SGS has established a related medical equipment laboratory in Taiwan, including electrical equipment safety tests, electromagnetic compatibility tests, mechanical function tests, biocompatibility evaluation, etc., to provide more convenient ONE STOP SHOPPING tests services.

In addition, SGS Taiwan has an excellent verification and audit team, which can provide customers with one-time integrated audit and evaluation services to meet the requirements of multiple standards, such as: ISO 13485, CE, CMDCAS certification at the same time, and We provide you with complete, professional and rapid tests services for medical equipment products and components in accordance with ISO, EN, ASTM, JIS and other international standards.

In order to help each other improve the ability from product design to finished product quality management, SGS Taiwan provides relevant medical equipment verification or technical training, so that customers can obtain certificate verification more quickly and make products successfully put into the market.

FOCUS

ISO 10993 BIOCOMPATIBILITY STUDY OF MEDICAL DEVICE SERVICES
ISO 10993 BIOCOMPATIBILITY STUDY OF MEDICAL DEVICE SERVICES
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ISO 18562 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS SERVICE.
ISO 18562 BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS SERVICE.
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MEDICAL DEVICE SAFETY TESTING
MEDICAL DEVICE SAFETY TESTING
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IVD PRODUCT SAFETY TESTING
IVD PRODUCT SAFETY TESTING
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PHYSICAL & MECHANICAL TESTS
PHYSICAL & MECHANICAL TESTS
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MEDICAL PACKAGE AND CONTAINER TESTING
MEDICAL PACKAGE AND CONTAINER TESTING
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Chemically related requirement of medical device
Chemically related requirement of medical device
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THE SGS FDA 3P510(K) PROGRAM
THE SGS FDA 3P510(K) PROGRAM
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ISO 13485 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM
ISO 13485 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM
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MEDICAL DEVICE SINGLE AUDIT PROGRAM, MDASP
MEDICAL DEVICE SINGLE AUDIT PROGRAM, MDASP
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EU MEDICAL DEVICES REGULATION
EU MEDICAL DEVICES REGULATION
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IN-VITRO DIAGNOSTIC DEVICES SERVICE
IN-VITRO DIAGNOSTIC DEVICES SERVICE
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IN-VITRO DIAGNOSTIC REGULATION
IN-VITRO DIAGNOSTIC REGULATION
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Knowledge Department - Taipei
FAX
02-22993231
ADD
No. 38, Wuquan Rd., Wugu Dist., New Taipei City 248016 , Taiwan (R.O.C.)