The Hong Kong Standards And Testing Centre Ltd (STC)

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 

Chemical Testing for Medical Devices

CMA Testing & Certification Laboratories Limited

At the stage of food selling, our product certification service can promote and strengthen the "good quality", "environmental friendly", "reliable"….images of your products which in turn enhance the consumers’ confidence.  Types of Service Examples Chemical testing Colorants, Metals, Veterinary Drugs, Sweeteners, Pesticides, Toxins, Preservatives, Antioxidants, Mineral Oils, Nutrition composition and labelling Biological testing Bacteria, Viruses, Parasites Others Species authenticity, Allergen testing, GMO testing, Shelf-life study, Audit service 

Food Testing

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/contact

Medical Devices Testing

At STC, our GMO &amp; DNA food testing capabilities are recognized under HOKALS accreditation to provide accurate and reliable testing services. Through extensive extraction and amplification of genetic materials via polymerase chain reaction (PCR) and DNA sequencing, we have the ability to unmask and identify any biological organism by analyzing their unique genetic codes.  Along with traditional food product safety testing, STC’s comprehensive testing capabilities also include molecular-based methods on microorganisms, traditional testing protocols for microbiological and antimicrobial effectiveness testing.  GMO Testing &amp;DNA Food Testing CaMV35S, NOS, etc. in GM FoodsCTP, Bt-11, etc. in soy, corn and their derived foodstuffDetection of GM Elements in rice, tomatoes, papaya, etc.Food Composition &amp;Product Safety Testing Allergic Substances(e.g. gluten, wheat, crustaceans, fish, peanut, soybean, nuts, etc.)Animal Ingredient Adulteration(e.g. porcine, bovine, fish, donkey, equine, etc.)Species Identification(e.g. animal and plant species)Valuable Medicine Authentication Species Identification in Products(e.g. Birds’ nest, Donkey-hide gelatin, Velvet Antler, Dried bulbous fritillaria cirrhosis, Cordyceps Sinensis, etc.) Bacterial &amp; Viral Testing Influenza A (Flu A) virus in food and the environmentFood-borne Pathogen and Viruses(e.g. Campylobacter, Norovirus, Hepatitis A, Rotavirus, etc.)If you have any further question, please feel free contact us or visit our website: https://www.stc.group/en/contact 

DNA Food Testing and GMO Testing

Tradelink Electronic Commerce Limited

Elevate your security with our customised MFA solutions meticulously crafted to match your specific requirements Experience the versatility of our MFA, perfectly tailored to maximised security and suit the unique demands of your business and industry, while complying with regulatory standards. Elevate Your Security and Efficiency with Tradelink's MFA Solutions Authenticated 5M+ usersIssued 1.4M+ certificates with zero faultsEffortlessly handles 1,200 authentications per second Is your business vulnerable to persistent password attacks? Microsoft deflects more than 1,000 password attacks per second on their system alone, and over 99.9% of compromised accounts don't have MFA. Don't wait for a security breach to take action. Act now and safeguard your customers' digital presence. Next-Level Security Beyond Passwords Biometric AuthenticationOur biometric authentication solutions adopt Fast Identity Online (FID) standard which can support different biological attributes for authentication, including face, voice, and fingerprint, etc.Features:Adopt FIDO Universal Authentication Framework (UAF) which can support different biological attributes for authenticationSupport multi-authentication factors in one single platformSupport various banking and finance services and processesSensitive personal data only stored on users' own mobile devicesDevice BindingOur device binding feature enables businesses to ensure that only authorised devices can access their customer's account, effectively minimising the chances of unauthorised access and fraudulent activities.Enables businesses to track user behaviour, investigate incidents, and maintain device-related audit trailsCustomers can effortlessly switch between devices or platformswithout the need for repeated authenticationPrevents unauthorised access to customer's accountEnables businesses to meet data protection and privacy regulationsDigital CertificatesEndorsed by HKSAR's Digital Policy Office, our wide range of digital certificates can be applied to validate and authenticate the identity of the party to a transaction, be it an individual or organisation. On-Premises Authentication Solution or Authentication-As-A-Service (AaaS) Tradelink offers both on-premises authentication solutions and cloud-based AaaS, enabling organisations of any size to cost-effectively meet their requirements for MFA. You can consider the below factors when choosing the ideal solution to deploy: Time to marketInfrastructure investment, including server and networkingMaintenance support, including upgrades and enhancementScalability of your service Endorsed by Leading Regulatory Authorities in Hong Kong  

Multi-factor Authentication

NAF Pharma Logistics Limited

Leading Expertise in Clinical Trial LogisticsNavigating the world of clinical trials is a complex process that requires precision, timing, reliability and careful coordination - They're the foundation of our business and the bedrock of every clinical trial logistics solution we offer.Welcome to NAF Pharma, we provide robust clinical trial supply chain management, ensuring full visibility, regulatory compliance, and a deep understanding of cross-border logistics.Trust us to be your reliable partner in your crucial research journey. Clinical Trial Logistics: Advanced Temperature Monitoring and Packaging SolutionsExperience our comprehensive suite of services designed to maintain optimal product conditions. From storage to transit, NAF PHARMA safeguards your clinical trial samples and treatments.‍Broad portfolio of packaging and temperature monitoring solutions to suit any requirement, regardless of the nature or size of your shipment.‍Specialist packaging for temperature-controlled hazardous goods, including dry ice, biological samples, radiopharmaceuticals, etc.‍Innovative data loggers designed to track and monitor the conditions of your treatments and samples during storage and transit. Direct-To-Patient Solution: A Step Forward In Making Clinical Trials More Patient FriendlyToday's clinical trial participants demand convenience and value their contribution. Our direct-to-patient logistics solution delivers clinical materials and collects samples directly from participants' homes, with meticulous handling and full data privacy. Fast, timed delivery of clinical materials from sites, pharmacies, or depotsPriority sample pickup and shipment to labs within the required time framesFull confidentiality between patient and sponsorTemperature-controlled shipments where neededCustomized solutions that comply with regulations in your country Global Expertise, Local InsightsOur global network is built on a thorough understanding of cross-border logistics. With years of industry experience, we've developed a keen acuity for navigating through the complexities of international regulations.Your shipments are always compliant, wherever you are based. Hence, our reach is global, but our service is personal. 

Clinical Trial Logistics

AKESO BIOPHARMA INC

   Therapeutic antibody generation service.   RIMMs like procedure.   Provide functional cellular assay screening.   Stable cell line for FACS.   Reliably produce high affinity antibodies quickly.   Generate hard-to-obtain antibodies.   Combine activating immune system and breaking immune tolerance using different sets of special reagents.   Use combined indirect ELISA and competitive ELISA for functional antibody screening.   Antibody/ antigen interaction.   Epitope binning/ mapping.   Antibody internalization screening.  

Therapeutic Antibody Generation and Assay Screening

NATIONAL JINGGANGSHAN ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE

Background:
The National Jinggangshan Economic and Technological Development Zone lies to the south of Ji&rsquo;an City, Jiangxi Province, China. It covers an area of 46.5 square kilometers. 
It has excellent and unique opportunities. The Jinggangshan Economic and Technological Development Zone, as a state-level economic and technological development area, has established a strong national exporting process. Serving as a base for the electronic information industry, a location for interaction with Taiwanese-funded enterprises and a key locale for the processing trade, the development zone is also home to the International Container Management Centre and has opened up a railway and sea transport link, connecting Ji&rsquo;an to Xiamen and Shenzhen.

Transport:
Jinggangshan also has the advantage of easy and convenient travel. It is contained within a six-hour travel area that includes the Pearl River Delta, the Yangtze River Delta and the southeastern part of Fujian. Jingganshan Airport has opened flights to major cities such as Beijing, Shanghai, Shenzhen, Xiamen, Guangzhou, Chengdu, Xi&rsquo;an, and Hanghzou. 

Abundant resources:
Jinggangshan enjoys the advantages of its most abundant resource &mdash; its people. Ji&rsquo;an City has a workforce of 2.4 million people, with 55 higher education institutions (including some junior colleges and vocational schools). 100,000 technical workers are available on a yearly basis to work in a city that always has a strong and abundant power supply. 

Industrial advantage:
Finally, the zone has been solidly building an industrial advantage. Within the development zone, large-scale industrial clusters have been formed, dominated by the varied industries of electronics information, biological medicine, food processing, advanced manufacturing and modern services. These new industries have been merged with firms in the surrounding industrial areas, meaning that the cluster effect has been beneficial in growing the development zone as a whole.


National Jinggangshan Economic and Technological Development Zone

FUZHOU HI-TECH DEVELOPMENT ZONE

Background: 
In 2005, the Fuzhou Hi-Tech Industrial Zone came into being in the New District of Fuzhou City. An announcement of its formation came from six ministries, notably the National Development and Reform Commission, the Housing Department and the Ministry of Land and Resources. Forty-five-percent of a 40-square-kilometre planning area has been developed.

Location and transportations:
The zone&rsquo;s location brings significant advantages as part of a golden region to promote development of the Yangtze River Delta, the Pearl River Delta and the west side of the Taiwan Strait. Its traffic advances include five highways and two high-speed railways. The zone forms the node of a &ldquo;five-hour-travel economic circle&rdquo; for Fuzhou, Wuhan, Changsha, Hangzhou, Hefei and Nanjing.

Competitive advantages:
Many competitive advantages exist. Electricity, water supply, drainage, sewage, land formation and communications throughout a 20-square-kilometre area have achieved &ldquo;five-outlet-one dish&rdquo;, &ldquo;eight-vertical-11- horizontal&rdquo; network and main road clusters, vaulting the zone into an overall lead in every respect.

Financial supports:
A good financial environment exists too. As a first financial support entity for Jiangxi Province&rsquo;s economic demonstration areas, the zone has built a financial services platform for comprehensive co-operation with 11 financial institutions. Nine such institutions have set up hi-tech-zone banks to protect enterprise loans and for &ldquo;Choi Garden credit&rdquo; and other financial products. More organizations also provide increasingly high quality, efficient and safe financial services for enterprises.

Industrial resources:
Industrial resources are multiplying. Relying on a national-level chemical-industry base and provincial-level automobile-and-parts and pharmaceutical production bases led to the emergence of leading enterprises like the massive Jiangling automotive group, textile machinery manufacturers and pharmaceutical giants, plus chemical, biological, veterinary medicines, drugs packaging and medical logistics specialists. An electronic information industry shows enormous potential, led by the likes of Senhong, Senke and DBK. The zone has become one of the best catalyst and fusion areas for industry and production anywhere in the developed areas along China&rsquo;s eastern coastline.

Environment:
The zone has an efficient development environment. It always pursues the concept of developing technology, science and a technology park. Meanwhile, it adheres to an open concept, one of not doing everything, relying on preferential and incentive policies involving land supply, financial support, fees, foreign investment, overseas exports and free employees&rsquo; training while striving to advance new industries.

Today&rsquo;s zone stays vibrant, a potential investment treasure with unlimited prospects and business chances. It overflows with hope and breeds positive prospects in an entrepreneurship paradise complete with proper operating costs, strong policy support, solid investment platforms and simple procedures, all ideal to boost development.


Fuzhou Hi-tech Development Zone

Neuro Quantum Asia Limited

The SCIO (scientific consciousness interface operations system) is a universal electrophysiological biofeedback system. It coordinates a complex electro-modal, biofeedback program with computer software in order to gather bioenergetic information of a client. The information is gathered from the body through electrodes in head and limb straps providing an accurate and precise picture of the client&rsquo;s general status.
 
  Electrophysiology multi-parameter Biofeedback. 
  Monitoring Sports training and Performance. 
  For Parkinson, Alzheimer, Epilepsy. 
 

My Sourcing