Laserfiche International Limited

Cloud Content Management for Higher Education Laserfiche helps universities digitize documents, automate workflows, and securely manage student and faculty data — freeing staff to focus on education and research, not paperwork. As institutions across Asia modernize, Laserfiche brings proven experience from universities worldwide, helping campuses reduce costs, accelerate admissions, and deliver digital-first services that meet rising student expectations.  Our Solutions Accelerate Admissions and Enrollment: Process applications faster by automatically extracting data from transcripts, essays and recommendations.Streamline Financial Aid: Speed up aid decisions by pulling data from tax returns and worksheets directly into financial systems.Automate Faculty HR: Digitize hiring contracts and compliance paperwork to onboard professors quickly.Boost Student Experience: Provide digital services and self-service portals that eliminate delays and improve transparency.Unlock New Insights: Better understand your data, optimize operations and improve decision-making.Why Choose Laserfiche Global SaaS leader in intelligent content management and process automationProven results across North America, Europe and Asia Explore how Laserfiche can accelerate your organization’s digital transformation.Schedule a Demo  

Build a Future-Ready Campus with Cloud Content Management

Lion Consulting Limited

Lion Consulting, Limited is a Licensee of the Trust and Company Service Provider (License No: TC006204) with the Companies Registry under the Anti-Money Laundering and Counter-Terrorist Financing Ordinance (Cap. 615).  We are based in Hong Kong with offices in Shenzhen, Guangzhou, Shanghai and Singapore.We assist client to setup company in Hong Kong and China. Apart from company formation, we are also provide a comprehensive corporate service that assisting client to comply with the requirements of company laws in Hong Kong and China. Lion Consulting (Shenzhen) Ltd. is a member of Lion Group, registered in China to service clients in Mainland China. Lion Consulting Pte. Ltd.(Lion Singapore) is Lion Group Member registered in Singapore. Lion Singapore is the Chartered Accountants Firm, Registered Filing Agent and Registered Tax Agent in Singapore to offer professional services to clients in ASEAN areas.We are not just only to provide company formation service to certain region, but we are also assist client to comply with the requirements of the local company laws.Culture difference is another major factor that affect the operation of a organization setup by foreign investor. We are familiar with the culture in those areas, we act as bridge between two different cultures and assist client to manage this issue, as well as increase productivity. 

Hong Kong, China, Singapore and Overseas Company Formation Services 

The Hong Kong Standards And Testing Centre Ltd (STC)

STC’s product safety testing services covers LVD testing to assist manufacturers in meeting CE Mark requirements.    The LVD covers health and safety risks on electrical products operating with an input or output voltage of between: 50 and 1000 V for alternating current75 and 1500 V for direct currentIt applies to a wide range of electrical equipment including:Household Electrical Appliances(e.g. coffee machines, refrigerators, microwave ovens, etc.)AV Products(e.g. TV sets, radios, video players, etc.)Luminary (Lighting) ProductsIT &amp; Office EquipmentCablesPower Supply UnitsLaser EquipmentElectrical Accessories &amp; certain components(e.g. fuses)Common Electrical Safety Testing Although commonly referred to as electrical safety testing, the actual assessments carried out extend well beyond a product’s electrical characteristics and includes: Electric Shock Hazards TestingEnergy Related Hazards TestingFlammability TestingHeat Related Hazards TestingMechanical Hazards TestingRadiation TestingChemical Hazards TestingAbnormal Operation Testing(faults and failures within the equipment)If you have any further question, please feel free contact us or visit our website: https://www.stc.group/en/contact 

Low Voltage Directive (LVD) Testing

Chemical for Toys and Children's Products EU Directive 2009/48/EC include:CMR Substances (Concentration Limits)	Cat 1A	Cat 1B	Cat 2Fragrances (Concentration Limits)Nitrosamines and Nitrosatable Substances (Migration Limits)Restricted Substances Listed in Appendix C of Annex II	TCEP	TCPP	TDCP	BPA	BIT	CMI	MI	CMI:MI	Formamide	PhenolIf you have any further question, please feel free contact us at enquiry@stc.group or visit our website: https://www.stc.group/en/services/detail/european-toy-safety

EU Directive 2009 48 EC Chemical Testing

CW Business Services Limited

CW Business Services Limited's China consultancy team is well-versed in helping foreign companies to establish their presence in China. They carefully examine business plans and help choose the proper organizational form, define the appropriate business scope, corporate governance structure, registered capital and avoid common pitfalls.  Setting up a foreign-invested enterprise (FIE) in China: Entry model, location selection, and business structure analysis.Advisory on the notarization and legalization process for the certificate of the shareholding company.Guidance on Chinese company name, registered capital, business scope, management structure, etc.Completion of government forms required for the company set-up.Collection of business licenses and company chops.Assistance in opening corporate bank accounts. Auxiliary services related to setting up a company in China: Search of a business office based on your budget expectation and government requirements.Assist in the negotiation with the property owner and the signing of the office rental agreement.Translation of documents in foreign languages.Introduction of potential business partners within our network to help you develop your business.

Foreign-Invested Enterprise Establishment in China

China — a vast country covering approximately 9.6 million square kilometers — is for a business looking further afield, beyond its national borders “the place to be”. Being one of the world’s fastest-growing economies, China is the epitome of growth and opportunity and is considered by many to offer the best investment proposition. As your well-networked trusted advisor, CW can connect you with the Chinese market and help you realize your ambitions of global expansion by setting your China entry and development strategies, and creating new opportunities for business development in China. We deliver deep and lucid insight to our clients so that they can better understand their markets and make sound investments. The sheer breadth and depth of our market knowledge allow us to provide tailor-made business planning and implementation support, while at the same time safeguarding clients’ interests in the form of market diagnosis, business planning, and implementation support: Advisory &amp; Consultancy - Having clear business objectives is essential for our work. What you want to achieve and how you intend to operate your business will be the key to finding the most appropriate entry model to China. Whether you are buying from China or selling to the Chinese market, a well-structured business must incorporate the application of the relevant local laws and compliance rules into the initial planning.Implementation Support - We are a team of professionals from tax, accountancy, and legal backgrounds driven by passion and a strong sense of practicality in dealing with China issues. By keeping abreast of changes and developments in the macro-environment, we are ideally placed to help and guide international clients in sailing through the mainland Chinese market.

China Consulting

(Clone) China Consulting

STC's Biocompatibility Testing services for medical devices includes:	Absorbent Incontinence Products  	Adhesives     	Blood Collection &amp; Storage Devices  	Bone Void Fillers  	Central Nervous System Implants	Combination Products 	Contact Lenses   	Dental Implants  	Devices Containing Antimicrobials	Device Raw Materials	Hemodialysis Disposables	Implantable Drug Delivery Devices  	Infusion / transfusion Devices	Intraocular Lenses	Laparoscopes &amp; Endoscopes  	Ocular Implants	Orthodontic Devices	Orthopedic Implants	Ostomy Devices	Reusable Devices	Surgical Gloves	Sutures	Syringes	Urinary Stents	Urologic Catheters	Vascular Catheters	Vascular Grafts	Vascular Stents	Ventricular Assist Devices	Wound Drainage Devices	Wound DressingsCytotoxicity Study Test (3 weeks lead time)	MTT Method(ISO 10993-5)	Agarose Overlay Method(ISO 10993-5 / USP 87)	Filter Diffusion Method(ISO 10993-5)	Direct Contact Method(ISO 10993-5 / USP 87)	MEM Method(USP 87)Irritation &amp; Skin Sensitization Test	Skim Sensitization Study (GPMT / Closed-patch)(ISO 10993-10) (6 - 8 weeks)	Skin Irritation Test(ISO 10993-10) (3 weeks)	Intracutaneous (Intradermal) Reactivity Test(ISO 10993-10 / USP 88)(3 weeks)	Oral Mucosa Irritation Test(ISO 10993-10) (8 - 10 weeks)	Vaginal Irritation Test(ISO 10993-10) (8 - 10 weeks)	Penile Irritation Test(ISO 10993-10) (8 - 10 weeks)	Rectal Irritation Test(ISO 10993-10) (3 months)	Ocular Irritation Test(ISO 10993-10) (3 - 4 weeks)Systemic Toxicity Test	Acute Systemic Toxicity Test(ISO 10993-11 / USP 88) (3 weeks)	Subacute Systemic Toxicity Test (14 days / 28 days)(ISO 10993-11) (6 or 8 weeks)	Subchronic Systemic Toxicity Test (90 days / 180 days)(ISO 10993-11) (5 or 8 months)	Pyrogen Test(ISO 10993-11) (3 weeks)Local Effects after Implantation Test(ISO 10993-6) (at least 4 weeks)	Implantation in Subcutaneous Tissue Test	Implantation in Muscle Test	Implantation in Bone TestInteractions with Blood Test (2 weeks)	Hemolysis Test(ISO 10993-4 / GB)	Hemolysis Test(ASTM F756)	APTT、PT、TT、FIB(ISO 10993-4 / GB)	Platelet Count Test	Complement Test(ISO 10993-4 / GB)	Thrombosis Test(in Vivo / in Vitro)(ISO 10993-4 / GB)Genotoxicity Test (ISO 10993-3)	Ames Test(8 weeks)	Mouse Lymphoma Assay Test(10 weeks)	Chromosome Aberration Test (10 weeks)If you have any further question, please feel free contact us atenquiry@stc.groupor visit our website:https://www.stc.group/en/contact

Biocompatibility Testing Services for Medical Devices

Intertek Testing Services Hong Kong Limited

The requirement for toy testing become increasingly stringent with each day that passes. Many countries have established their own safety regulations for toys and you must ensure that your products comply with relevant standards before your goods can be sold in these locations. Manufacturers have been held liable for injuries and fatalities resulting from design flaws, use of unsuitable materials and substandard production.  As the largest players in toys, games and premium testing industry with over 1,000 laboratories and offices in over 100 countries, Intertek can help safeguard its clients - providing product safety testing, certification, inspection, evaluation and quality assurance services including:  Smart Toys TestingToys Testing for the Japan MarketPet Product Testing ServicesSafety AssessmentDesign Hazard AnalysisPre-shipment InspectionCPSIA Testing (Consumer Product Safety Improvement Act )ASTM F963 Toys Testing StandardCPSC Regulatory TestingNew EU Toys Safety Directive Compliance TestAustralian Toys Testing Standard AS/ NZS ISO 8124EC Type ExaminationGB Toys Testing StandardGSO Conformity Tracking Symbol is Now EffectiveGCC Product CertificationKC Mark Certification

Toy Testing

The Hong Kong Electronic Industries Association Limited

 The annual directory is an invaluable reference book covering over 5,000 Hong Kong electronics companies. Every HKEIA member is listed in it and this directory is provided free of charge for members.    An easy and effective way to find trading partners.   Different publications available.  

Annual Directory of Hong Kong

Man Sang Envelope Mfg Co Ltd

   VIP Specialist Service Team The Establishment of the “VIP Specialist Service Team”   Man sang established “VIP Specialist Service Team” to serve different kinds of customers. We are now also direct to“Non-Standard Product” and “Specialist follows up” for VIP large amount printing order, to provide caring printing on inquiry and specialist follow up service.  Members of “VIP Specialist Service Team” are including sale and production technical, our aim is to use professional technology and experience, to serve the best printing service can help customers to solve the problem and monitor products process; hence customer will be feeling at ease to choose e-print.    VIP Specialist Service Introduce  Established of e-print “VIP Specialist Service Team”, customer can choose “Specialist follow up” service for “Non-Standard Product”. Example: Special Finishing, Special Die Cut, Mounting, Own paper, Special Paper, Screen Printing, Packing Box, Wire-O Binding, Paperback (Hardback), Packaging Service, Variable Printing Service, Address Mailing, Plastic Box, Spot Color Printing and so on.   

VIP Perfume Specialist Packaging Service and Design Team

Weprovide high-quality testing services for sunglasses and sun glare filters. Our testing standards meet the EU directive requirements, and wehelp you to develop business in EU markets. Our test scope includes blue-light absorption, UV absorption, scattered lights, lens robustness, resistance to ignition, lens transmittance uniformity, polarizing filters, gradient filters, material and surface quality, and resistance to radiation.	EU directive of Personal Protective Equipment (PPE) 89/686/EEC specifies the fundamental safety requirements for sunglasses.	All sunglasses are required to meet the fundamental safety requirements EN 1836:2005.

Sunglasses and Sun Glare Filter Testing

Chemical for Electric Toys and Children's Products EU Directive 2011/65/EU: ROHS 2Following substances are restricted:	Lead	Cadmium	Chromium VI	Polybrominated Biphenyls (PBB)	Polybrominated Diphenyl (PBDE)	Bis (2Ethylhexyl) Phthalates (DEHP)	Butyl Benzyl Phthalate (BBP)	Dibutyl Phthalate (DBP)	Diisobutyl Phthalate (DIBP)	MercuryIf you have any further question, please feel free contact us at enquiry@stc.group or visit our website: https://www.stc.group/en/services/detail/european-toy-safety

EU ROHS Chemical Testing

 Toy Safety Testing 
STC offers comprehensive testing services to ensure the safety and regulatory compliance for toys and children&rsquo;s products entering the European market. Our European Toy Safety Testing services include:
&nbsp;
 The EU Toy Safety Directive 2009/48/EC 
All toys that are sold in the European Market must meet the standards set out in the EU Toy Safety Directive 2009/48/EC to ensure that the product is safe and fit for its purpose.
&nbsp;
 EN71 Testing  	 EN71 Part 1 &ndash; Physical and Mechanical Test 	 EN71 Part 2 &ndash; Flammability Test 	 EN71 Part 3 &ndash; Migration of Toxic Elements Test 	 EN71 Part 4 &ndash; Experimental Set for Chemistry 	 EN71 Part 5 &ndash; Chemical Toys (Sets) Other than Experimental Sets 	 EN71 Part 7 &ndash; Finger Paints 	 EN71 Part 8 &ndash; Swings, Slides &amp; Similar Activity Toys for Indoor &amp; Outdoor Family Domestic Use 	 EN71 Part 9 &ndash; Organic Chemical Compounds 	 EN71 Part 12 &ndash; Nitrosamines &amp; Nitrosatable substances 	 EN71 Part 13 &ndash; Fragrances in Certain Toys 	 EN71 Part 14 &ndash; Trampolines for Domestic Use  If you have any further question, please feel free contact us at enquiry@stc.group or visit our website: https://www.stc.group/en/services/detail/european-toy-safety

European Toy Testing EN71

Our Electrical Products Division offers a wide range of services to ensure the safety of office and home appliances, including:	Providing technical support services at different design stages	Offering a full scope of electrical safety testing service	Providing one-stop product safety testing and certification services according to customer specifications and relevant product standards, e.g. screening test for RoHS, tests for PAHs and California Energy Efficiency testVoltage Regulating Devices Safety Test:	Isolating Transformer	AC/AC Adaptor	AC/DC Adaptor	Switching Power Supply (Single output)	Additional charge for Direct plug-in type: ABR4, EN50075, AS/NZS 3112 Annex J

Voltage Regulating Devices Safety Test

V-Trust Inspection Service Co., Ltd

V-Trust's testing and certification services provide essential support to buyers, ensuring that toys meet both customer specifications and European Union safety standards. EN 71 Testing Overview The EN 71 standard, part of the European Toy Safety Directive (2009/48/EC), specifies safety requirements for toys sold in the European market. It addresses various hazards, including mechanical and physical risks, flammability, and the presence of harmful chemicals, ensuring toys are safe for use by children. EN 71 Compliance Requirements Comply with all applicable EN 71 parts, including:EN 71-1: Mechanical and physical properties.EN 71-2: Flammability.EN 71-3: Migration of harmful chemical elements (e.g., lead, cadmium, mercury).Additional EN 71 parts depending on the product (e.g., finger paints, electrical toys).Test products through an accredited laboratory to ensure compliance.Maintain a technical file with testing reports and compliance documentation.Affix the CE marking to the product, indicating conformity with European safety standards.What Products Should Be Tested? EN 71 applies to all toys or products targeted at children under 14 years of age. This includes products such as dolls, stuffed animals, puzzles, construction sets, educational toys, electronic toys, ride-on toys, and arts and crafts materials.  Why Choose V-Trust? V-Trust delivers accurate EN 71 testing within 3-5 working days, helping buyers ensure safety, compliance, and market readiness. 24/7 customer service supportFree consultancy on EU and global toy safety regulationsCost savings of up to 20% compared to other testing providersOne-stop service from sample collection to lab testingAbout V-Trust We are experts in the quality control industry, offering a wide range of cost-effective services, including product inspections, factory audits, laboratory testing, and product certification. V-Trust operates in China and key export markets such as India, Vietnam, Malaysia, Thailand, Bangladesh, Pakistan, Cambodia, Indonesia, and Myanmar. For more information, please contact us: Website: www.v-trust.com 

EN 71 Testing – European Toys Safety Testing

CMA Testing & Certification Laboratories Limited

Country Related Standards and Regulations EU Testing for CE Marking- LVD (Low Voltage Directive)- EMC (Electromagnetic Compatibility Testing)- EMF (Electromagnetic Field) RED (Radio Equipment Directive) VDE GS Mark CB Scheme US California Energy Commission FCC (Federal Communications Commission) Australia and New Zealand AS/NZS regulations Japan VCCI (Voluntary Control Council for Interference by Information Technology Equipment) China China GB regulations Canada RSS (Radio Standards Specifications)ICES (Interference-causing Equipment Standards) GCC Standardization Organization GSO regulation 

Electrical and Electronic Testing

At STC, we provide energy efficiency evaluation, testing and certification for a wide range of electrical products in accordance to relevant labeling regulations and voluntary labeling standards.  Our Energy Efficiency Testing &amp; Certification services include:  Energy Efficiency Labeling Scheme-Hong Kong(IEC, CIE 84, GB) Compact Fluorescent Lamps(CFLs)(Mandatory*)Televisions (Mandatory*)Household Induction Cookers(Mandatory*)Non-integrated Compact Fluorescent lamps(CFLs)Automatic Electric Rice CookersMicrowave OvensComputersPhotocopiersFax MachinesPrintersMultifunction DevicesEnergy Performance Measure Testing-International &amp; Europe(Directive 2009/125/EC, IEC, EN) DC or AC Supplied Electronic Control Gear for LED modulesMeasurement of Standby Power for household electrical appliancesPower Consumption of audio, video and related equipmentEnergy Efficiency of electric lamps for household useTest Method for Calculating the Energy Efficiency of Single-Voltage External AC-DC Power SuppliesEco-design Requirements for: TelevisionsSimple set-top boxesNon-directional household lampsStandby &amp; off mode electric power consumption of electrical &amp; electronic household &amp; office equipmentNo-load condition electric power consumption and average active efficiency of external power suppliesFluorescent lamps without integrated ballast, for high intensity discharge lamps, &amp; for ballasts &amp; luminaries able to operate such lamps Energy Performance Measure Testing–United States CaliforniaAppliance Efficiency ProgramInternational Electro-technical Commission(IEC 62087)Energy Efficiency of Single-Voltage External AC-DC and AC-AC Power Supplies(USEPA)Energy Efficiency Battery Charger System Test Procedure Version 2.2(ECOS, EPSI)Electro-technical Commission(IEC 62301 &amp; IEC 62087,Title 20 Appliance Efficiency Regulations)Energy Performance Measure Testing– Australia &amp; New Zealand Performance of external power supplies – Test method and energy performance mark(AS/NZS 4665.1)Performance of external power supplies – Minimum energy performance standard requirementsIf you have any further question, please feel free contact us atenquiry@stc.group or visit our website:https://www.stc.group/en/contact 

Energy Efficiency Labeling

Toy Safety TestingREACHToys and children’s products manufacturers, distributors, retailers and importers are responsible for compliance and managing the risks associated with their chemical uses under the Annex XVII of REACH directive which contains the list of restrictions on certain hazardous substances, mixtures and articles for their marketing and use on the European market.​STC offers comprehensive testing services to ensure the safety and regulatory compliance for toys and children’s products entering the European market. Our European Toy Safety Testing services include:REACH Annex XVII Testing	Azodyes &amp; Azocolorants	Benzene	Cadmium	DMF (Dimethylfumarate) (2011/135/EU)	Lead in Jewelry Products	Nickel and its compounds	Nonylphenol(NP) &amp; Nonylphenol Epoxyentes (NPE)	Organotin (DBT, TBT, TPhT, DOT)	PAHs (Polycyclic aromatic hydrocarbons)	Phthalates Content in Plasticized Materials	SCCP (Short Chain Chlorinated Paraffins)	TolueneIf you have any further question, please feel free contact us at enquiry@stc.group or visit our website: https://www.stc.group/en/services/detail/european-toy-safety

European REACH Toy Testing

Bureau Veritas HK Ltd

Bureau Veritas Consumer Products Services (BVCPS), a division of Bureau Veritas, provides an array of concept-to-consumer quality assurance and compliance service. As shown is the restricted substances testing service we can provide.
    Azodye directive   Nickel directive   Phthalates directive   German food and commodities law  Dangerous substances directive   

Restricted Substances Testing Service

With an emphasis in Total Quality Assurance, Intertek can help you get the following certifications and access into the global market.  • CB Scheme • ETL Listed Mark for US and Canada • S Mark for EU • GS Mark for Germany • CE Mark for EU • ENEC Mark for EU • ASTA Mark for 3-pin plug  • BEAB Mark for EU • Qi Mark • Gulf Mark  • CCC Mark for China • KC Mark Korea • UKCA Mark for UK • Functional Safety Mark • RoHS, WEEE  • REACH • TCB (Telecommunication Certification Body) • OFCA LCB (Local Certification Body) for Hong Kong • ErP (Energy related Products Directive) • Saudi Arabia KSA PCP • Global Market Access Program • GCC Standardization Organization (GSO) • G Mark 

Global Certifications

SGS HK Ltd

Customer and consumer demands are driving up standards in the footwear and leather supply chain, presenting the industry with a range of challenges in order to remain competitive, profitable, and sustainable. Stakeholders are increasingly demanding products that are not only safe and of good quality but also, manufactured in an environmentally and socially responsible manner. From a product safety and quality perspective we conduct tests to verify that products meet the desired global requirements and standards, for example: volatile organic compounds (VOCs) in adhesives, excessive chromium VI in leather, and the risk of phthalates in plastic accessories associated with children’s footwear. Environmental and social responsibility concerns are assessed through inspection, audit, and certification of production facilities and workers’ occupational health and safety. Regulatory Compliance Our testing, inspection, and certification services can verify product compliance with one or more regulations, for as many markets as you require, such as: Canada: CCPSAChina: Product StandardsEU: REACH, Restricted Substances, SVHCs &amp; Directive 89/686/EEC for PPEKorea: KC Mark RegulationsTaiwan: CNS RegulationsUS: CPSIA, California Proposition 65, plus Washington State’s CHCCOur Services We offer a comprehensive range of services across the entire footwear and leather supply chain: Footwear and leather product testingECOSECURE product mark certification for footwear and leather productsMold prevention solutionFitting and sizing servicesSafety footwear certificationTechnical consultancyInspectionGovernment-mandated pre-shipment inspection (PSI) for selected emerging marketsSocial responsibility solutionsSystems and services certificationCarbon and energy efficiency solutionsTechnical audit of footwear factories and leather tanneries Design, manufacture, and deliver footwear and leather products that are more attractive to buyers with audit, testing, inspection, compliance services from SGS. 

Footwear & Leather Products Testing Services

Toy products are highly regulated throughout the world and toy safety standards are being constantly updated. Consumers need to be confident that the toys they buy for children are of high quality and are safe, whether from harmful chemicals, or design faults that could cause injury. SGS offers a one-stop solution to all your toy needs so that you can be sure your toys comply with relevant regulations and quality standards, such as the new EU toy directive and the US Consumer Product Safety Act (CPSIA). SGS aims to assure toy safety and offers a comprehensive program including: Support for new Product Development (Product specification verification, Technical/Design advice)Update and interpretation of legal requirementsSafety/Risk Assessment (product hazards analysis)Product and Materials TestingFactory and Social AuditsInspections (production control)Training (staff, suppliers)SGS provides manufacturers, retailers, and importers with comprehensive customized Quality Assurance Solutions for all toy needs: Plush toysDollsRide-on toysProjectile toysGamesFigurinesConstruction toysCreative art materialsPuzzlesPull along toysBattery operated toysRadio controlled toysInfant toysResidential playground equipmentChoosing us means you can be confident that our rigorous procedures throughout your supply chain will ensure that you comply with worldwide regulations and industry standards, ensuring your product’s entry into the market of your choice and minimizing the risk of costly toy recalls. Our toy labs are strategically located in key manufacturing zones and transit points worldwide. They are internationally recognized by major industry associations and accreditation bodies (CNAL, HOKLAS, COFRAC, UKAS, A2LA, BIS, amfori BSCI, ICTI, ISTA, etc.) and are known as a global benchmark in quality and integrity. 

Toy Testing & Certification Services

Characterization for materials used in medical devices – an analysis of a material’s composition, purity, uniformity, sterilant residuals and extractables – is an essential step to verify their suitability for human body contact, thus should not be missed out throughout the product life cycle.  Following the enforcement ofRoHS2 in the European Union, which restricts the use of specified hazardous substances in electrical and electronic equipment, and medical devices are now added to the scope of the Directive and have to be verified asRoHS-compliant.  The chemical laboratory at STC is equipped with the most advanced testing equipment; our team of experts can perform material characterization and RoHS analysis with a wide range of testing methods. We can help manufacturers identify the appropriate testing program based on the intended use of a device and material, and its expected nature of contact with the human body. Material Characterization - Guidelines &amp; Standards U.S. FDA Blue Book Memorandum GP#95-1ISO 10993-1, “Biological Evaluation of Medical Devices”ISO 10993-18, “Chemical Characterization of Materials”FDA Guidance Document, “Container Closure Systems for Packaging Human Drugs and Biologics” Material Characterization Testing Capabilities Physiochemical TestFourier Transform Infrared Spectroscopy (FTIR)High-Performance Liquid Chromatography/mass Spectrometry (HPLC-MS)Gas Chromatography / Flame Ionization Detector (GC / FID)Gas Chromatography / Mass Spectrometry (GC / MS)Inductively Coupled Plasma Spectrometry (ICP)Specific GravityGel-Permeation Chromatography (GPC)ViscosityDifferential Scanning Calorimetry (DSC)If you have any further question, please feel free contact us or visit our website: https://www.stc.group/en/contact 

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