The Hong Kong Standards And Testing Centre Ltd (STC)

Medical device regulations are constantly changing and evolving to better safeguard the health and safety of the public. However these regular changes may impact manufacturers with regards to their product requirements and registrations with local and overseas regulators.   At STC, our team of knowledgeable experts are up-to-date with the latest regulatory requirements in key markets to ensure that compliance is met and support medical device manufacturers in gaining market entry quickly.  Key Market Support: Australia(DOH)Brazil(MOH)Canada(HC)China(CFDA)Europe(CE Notified Body MDD / MDR)India(MOH)Japan(MHLW)Korea(MFDS)Malaysia(MOH)Singapore(HSA)Taiwan(TFDA)United States(FDA)Our Medical Device Product Classification &amp; Regulatory Support services include: Document Preparation for ISO13485 Certification (Gap Analysis)Medical Grade Components SourcingTechnical File / Dossier CompilingCollateral, Particular Harmonized &amp; Industrial Standards TestingTest Equipment Setup for Performance TestingBiological Testing according to GLP RequirementsSubmission of Technical File to RegulatorsRepresentation by Local RepresentativesLicense Holding &amp; Risk ManagementOn-site Support during Regulator InspectionsQMS/QSR support on CFR820, ISO13485, Canada MDR, Korea GMP, Brazil GMP and Japan Ordinance 169Electrical Testing ISO 17025CB SchemeNRTL Program. Biological Testing(ISO 10993) Interactions with blood(ISO 10993-4)Vitro Cytotoxicity(ISO 10993-5)Local Effects after Implantation(ISO 10993-6)Ethylene oxide sterilization residuals(ISO 10993-7)Irritation(ISO 10993-10)Skin Sensitization(ISO 10993-10)Systemic Toxicity(ISO 10993-11)LUCIDEON Medical Device Services As part of our commitment to offering the most extensive services to our customers, STC is working in collaboration with LUCIDEON to provide a greater range of services including Medical Device Consultancy, Materials Developments and Technology Innovations.If you have any further question, please feel free contact us or visit our website: https://www.stc.group/en/contactTo know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact.  

Medical Devices Testing

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

STC offers Safety &amp; Performance Testing services for medical device products such as: Electronic Clinical ThermometersInfrared ThermometersElectronic SphygmomanometersElectronic LaparoscopesElectronic EndoscopesElectrocardiographsMulti-parameter MonitorsPulse OximetersTherapeutic LampsHumidifiersNerve &amp; Muscle StimulatorsHigh-potential Therapeutic ApparatusElectro-therapeutic EquipmentMagnetic Therapy EquipmentHearing Aid General Standard General Requirements(EC / EN 60601-1) Collateral Standards Usability(IEC / EN 60601-1-6; IEC / EN 62366)Alarm System(IEC / EN 60601-1-8)Medical Electrical Equipment for Home Healthcare(IEC / EN 60601-1-11) Particular Requirements Nerve &amp; Muscle Stimulators(IEC / EN 60601-2-10)ECG Related Equipment(IEC / EN 60601-2-25; IEC/EN 60601-2-27; IEC / EN 60601-2-47)Sphygmomanometers(IEC / EN 80601-2-30; IEC/EN 60601-2-34; ISO / EN ISO 81060-1)Multi-parameter Monitors(IEC / EN 60601-2-49)Thermometers(ISO / EN ISO 80601-2-56)Light Source Equipment (IEC / EN 60601-2-22; IEC / EN 60601-2-57)Pulse Oximeters(ISO / EN ISO 80601-2-61)Hearing Aids(IEC / EN 60601-2-66)Additional Requirements(IEC / EN 60601-2-XX; IEC / EN 80601-2-XX, ISO / EN ISO 80601-2-XX; ISO / EN ISO XXXX)If you have any further question, please feel free contact us or visit our website: https://www.stc.group/en/contact To know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact. 

Safety and Performance Testing Services for Medical Device Products

ATR Manufacturing Ltd

We provide EMS solution. Our service includes OEM, OBM and ODM manufacturing. Our product experience includes Medical and Healthcare Equipment, Electric Appliance Control Units, Hospital Equipment, Temperature Monitoring Devices, Deodorizer, Light Tube, Safety and Security Equipment, Assistive Hearing Devices, Communication Equipment, Pest Control Units, Currency Handling Devices and PCB Assemblies. Our existing manufacturing plant is in Dongguan, China. We will have a new plant in Vietnam starting for Production by January 2020 at Phase-1; the Phase-2 facilities will be scheduled completion by end 2020.

OEM / ODM / EMS Manufacturing

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 To know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact. 

Chemical Testing for Medical Devices

Microbiological testing for assessing the microbiological characteristics of finished devices, manufacturing process and manufacturing environment can help eliminate or minimize the risk of microbial contamination, hence the risk of infection to patients, users or third parties.  STC offers a comprehensive scope of microbiological test to assist medical device manufacturers in meeting the microbiological and sterilization safety requirements for regulatory approval.  Testing Capabilities Bioburden TestEndotoxin DeterminationSterility TestPackage integrity TestShelf Life / Life-Cycle ValidationMicrobial IdentificationCompendial TestingAntimicrobial ChallengeCleaning ValidationCustomized Microbial AssessmentsMicrobiological Limits TestWater Sampling &amp; Testing for Sterility &amp; Microbiological SafetyIf you have any further question, please feel free contact us or visit our website:https://www.stc.group/en/contact To know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact. 

Microbiological Testing for Medical Devices

STC offer Electromagnetic Compatibility (EMC) Testing services for medical devices such as: Medical Electrical EquipmentIn Vitro Diagnosis (IVD) Medical EquipmentElectromagnetic Compatibility Testing (EMC) IEC / EN 60601-1-2CISPR 11 / EN 55011IEC / EN 61326-1IEC / EN 61326-2-6FCC Part 15 / Part 18ICES-001 / ICES-003 Radio Frequency Testing (RF) EN 300330-1; EN 300330-2 (9 kHz to 30 MHz)EN 300220-1; EN 300220-2 (25 MHz to 1000 MHz)EN 300440-1; EN 300440-2 (1 GHz to 40 GHz)FCC Part 15 / Part 18; RSS-210Bluetooth EN 300328 (2.4 GHz)FCC Part 15 / Part 18RSS-247Wi-Fi EN 300328 (2.4 GHz TRx WiFi b / g / n)EN 301893 (5.8 GHz)FCC Part 15 / Part 18RSS-247If you have any further question, please feel free contact us or visit our website: https://www.stc.group/en/contacTo know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact.  

Electromagnetic Compatibility for Medical Devices

Herald Datanetics Limited

HDL serves startup companies, leading Smart Home and Home Security providers, professional industrial service providers, Health &amp; Telemedicine companies and Fortune 100, etc.  HDL can ramp up products from small quantity of samples (for certification, market testing) up to huge volume demand (with continuous improvement). We have our owned factory located on 200,000 ft2 of land in Zhuhai, China. We can easily expand our production facilities and production line to fulfil customers business need with automation. 

OEM/ODM Contract Manufacturing Service

Svi Public Co Ltd

Electronic manufacturing service, start from PCBA to Final Assembly. Factories located in Thailand, Austria, Slovakia and Hungary. 	 Audio 	 Medical 	 Telecommunication 	 Industrial 	 Transportation 	 etc.,  

Electronic Manufacturing Service - Medical Product

Electronic Manufacturing Service
Our industry focus includes industrial products, high end telecommunications, office automation, professional audio and video products, automotive electronics, medical devices, etc. The advanced solutions are sure to keep you on the cutting edge.

Electronic Manufacturing Service

We provide fully turn-key solutions that integrate innovative EMS products with quality manufacturing. Our industry focus includes industrial products, high end telecommunications, office automation, professional audio and video products, automotive electronics, medical devices, etc. The advanced solutions are sure to keep you on the cutting edge.
 
  Covering a wide industry. 
  Experienced in this field. 
 

EMS Turn-Key

The Chinese University of Hong Kong

This is a smart bio-disc system for performing low-cost nucleic acid screening of tuberculosis (TB) from sputum samples. Low-cost point-of-care genotyping devices offering rapid screening of infectious disease such as TB, hence minimizing the chance of transmission, will lead to drastic cost savings on treatment. An important technological breakthrough of our &quot;Intelligent Bio-disc Platform&quot; (IBP) comes from the delivery of electrical power to the bio-disc.
 
  This has overcome a major bottleneck in existing lab-on-a-disc designs because many previously impossible yet necessary functionalities such as flow metering, sample heating and real-time signal detection, may now be realized with the supply of electricity. 
  The use of centrifugal actuation offers many advantages including low device complexity, limitless parallelization and availability of actuation force anywhere on the disc. 
 

Intelligent Bio-Disc Platform

 	 Full service EMS 	 Including Product Design/Development 	 PCBA to System Build, advanced production automation &amp; test 	 Cleanroom assembly 	 PLM services  

EMS services - Medical and Automotive

Pantene Industrial Co Limited

 	 An Established designer, developer and manufacturer of high quality products and services to its OEM and electronics industrial partners.&nbsp; 	 We have rich experience in EMS manufacturing service including design, engineering solutions and service world&rsquo;s famous brands for years. Also, highly sophisticated vertical integration provides one-stop manufacturing service from product design to mass production.  

OEM/EMS Product Design Service 

Bureau Veritas HK Ltd

  Art and Craft Toys  Battery Operated Toys  Carriage & Stroller  Electrically Operated Toys  Food Contact Plastic Toys  High Chair  Liquid   Filled Toys  Metal Omament & Fashion Accessories  Pacifiers  Playyard  Stuffed Toys  Toy Cosmetics  Toy Sunglasses  

EMC Testing for Battery-operated Toys

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 To know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact. 

Low Voltage Directive (LVD) Testing

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 stagesOffering a full scope of electrical safety testing serviceProviding 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 TransformerAC/AC AdaptorAC/DC AdaptorSwitching Power Supply (Single output)Additional charge for Direct plug-in type: ABR4, EN50075, AS/NZS 3112 Annex JTo know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact. 

Voltage Regulating Devices Safety Test

AT-Vibe Technology Limited

Care 24 Hrs Elderly Health &amp; SafetySmart Monitoring System - AUTO SOS Instant AlertMulti-Channel Notification - Privacy Protection No Cam No Worry Suitable for bathroom, toilet, kitchen,balcony, living room, hallway, staircase... - High Accuracy Fall Detection Not affected by environmental factorssuch as light, temperture, humidity... - User-friendly Safe Frequency Wireless, Touchless, No Physical Restraint Easy Installation No Extra Manpower Increase Safety and Efficiency 

Inno-health Care

Dummies, Pacifiers, Soother Holders and Bottles.  At STC, our baby product testing specialists are up-to-date with constantly changing global regulatory requirements and industry standards to ensure that products are compliant and competitive.  Our state-of-the-art internationally recognized and accredited testing laboratory allows us to perform infant product testing in accordance to Australia, Europe, United Kingdom, United States, Canada Hazardous Products (Pacifiers) Regulation and Australia/New Zealand .  Our extensive Infant Baby Product Testing services include: Baby Product Testing Baby Dummies (ASTM F 963, 16 CFR 1511, EN1400, AS2432)Baby Soother Holders (EN12586)Baby Carriers (ASTM F2236, EN13209)Bottle and Bottle Teats (EN14350)Changing Units (ASTM F2388, EN12221)Infant Bouncer Seats (ASTM F2167, 16 CFR 1229, BS EN 12790)Children's Cutlery &amp; Feeding UtensilsIf 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/childrens-juvenile-products To know more or enquire any specific service, please visit https://www.stc.group and fill in our enquiry form on https: www.stc.group/contact. 

Infant Products Testing

Unitronics Company Limited

Unitronics brings a high level of knowledge and experience to the projects of 2.4G wireless communication, networking, innovation Toys and consumer devices with Apps, which permit us to offer our clients flexible and proactive solutions to the toughest challenges.  Our software design services include: Apps solutionBack-end development – AWSPC

Software Design & development

V-Trust Inspection Service Co., Ltd

Wide Expertise in the Home Appliances Industry  V-Trust's inspection services for home appliances provide invaluable support to buyers, ensuring that products comply with safety requirements and quality standards.  By identifying potential defects, electrical hazards, and performance issues before products reach the market, V-Trust helps buyers mitigate risks and avoid costly problems.  Detailed inspection reports with photographic evidence available within 6 to 24 hours after inspection.  Why V-Trust  ✔ Full-Time Inspectors Only: We do not hire part-time QC staff or outsource to other firms. This approach serves as a key anti-bribery measure and ensures the highest level of reliability in our inspection reports. ✔ Diverse Product Range: Our team covers a wide range of product categories, including electronics, electrical products, lighting, building materials, furniture, home décor, kitchenware, textiles, apparel, and industrial goods. ✔ 2,500+ Checklists: We offer comprehensive checklists for various product lines, drawing on our extensive QC experience. ✔ Online Booking: Easily book services through our advanced online system, and access inspection results and supply chain statistics via the QC dashboard. ✔ Quick and Efficient Service: Receive same-day quotations, with reports available 6 to 24 hours after inspection. We also offer free laboratory testing and regulatory consultations.  About V-Trust  V-Trust is the largest product inspection company in Asia, employing only full-time inspectors. With over 600 staff across 10 Asian countries, we conduct more than 110,000 inspections and audits annually, serving over 13,000 buyers worldwide.  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 

Home Appliances Product Inspection

TUV Rheinland HK Ltd

Our company produces, tests and certifies&nbsp;a wide spectrum of&nbsp;electrical and electronic products including electrical household appliances, power tools, garden tools, audio and video equipments, office equipments, laser products, electronic components, and luminaries.&nbsp;With your best interests at heart,&nbsp;our products strictly&nbsp;comply&nbsp;with high quality and safety standards. 	 Excellent craftsmanship. 	 OEM is welcome.  

Electrical and Electronic Products

We provide professional quality control services for various kinds of industries. Our services include various detailed tests with accurate data for your products. The services are also provided quickly within a short period upon request. 	 Quantity status 	 Product appearance 	 Performance and function tests. 	 Workmanship&nbsp; 	 Assembly 	 Accessory 	 Material 	 Color 	 Logo 	 Size measurement 	 Weight 	 Assortment 	 Carton status 	 Bar code scan test 	 Packing and marking 	 Shipping marks.  

Electronics inspection

Information Processing Consultants Ltd

Proactive Individual Caring System(PICS) is an award-wining software solution designed for elderly Homes and Homes for under-privileged individuals who need special cares in their daily lives. PICS is developed since 2016 by IPc and has been implemented in many Homes in Hong Kong and Macao since its launch in subsequent year. PICS was awarded silver medal in ICT2018. It composes of two main modules, namely, Homes Administration and Drug Administration. These two modules are seamlessly integrated to form a comprehensive Individual Caring System for Homes aiming at proactively avoiding occurrence of adverse incidence.  Before resident admits the Home, pre-assessment is administered so that preparatory work is ready. Home administration includes creating resident personal and clinical profiles, and establishing individual caring plan (ICP) for each resident. The ICP records vital signs, wound positions, dentition, and caring schedule. This schedule serves as reminder of events to be alarmed in carrying out the daily routines such as taking drugs, measuring vital signs like blood pressure, blood sugar level, blood oxygen level, and pulse. These vital signs can be transmitted to PICS via Bluetooth provided these instruments are verified by IPc technical team.  Drug administration includes inventory of drug dispensary. This in-house pharmacy dispenses drug to resident according the prescription of medical officer (MO). PICS alerts adverse drug reactions (if any) that may occur when drugs are dispensed to resident. Nurses and care takers use Android tablet PC while they are administering drugs to residents. The tablet PC displays the photo of the resident along with the one-to-one photo of each drug as part of the three-verification-five-check paradigm in drug dispensing. The drugs dispensed are recorded at spot as electronic medical administration records (eMAR). MAR is mandated by Government of Hong Kong and Macao.  PICS also includes a module for in-house/visiting MOs to record diagnosis and prescribe at spot the drugs for residents. These prescriptions immediately appear in the in-house pharmacy. This process accelerates the dispensing time and ease the work of MOs. Drug administration module can be extended to drug packaging which greatly relieves the burden of nurses in Homes as drugs are packed per each in-taking of drug. Currently, PICS seamlessly interfaces with JVM and Yuyama drug packaging machines.  IPc wholly-owns the intellectual property of PICS. Should customisation, such as community drug centre, be mandated, IPc has the rights and capability in customizing new features for Homes.   To promote PICS so that total cost of ownership is kept to the minimal, PICS is available as Software as a Service (SaaS) approach in implementation. Homes just pay a monthly subscription fee instead of paying huge one-time license fee which has included computer servers and software and saved expenses of in-house IT staff.  

My Sourcing