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Medical Device Testing and Certification

Testing and Certification Solutions for All Medical Devices/ IVD Devices

About HTW Lab:

HTW Lab can guide you through the testing process step by step for your medical device products, and help you meet regulatory standards for global market access. For technical regulation support, technicians at HTW are able to help you understand technical regulations and product design specifications. 

We are experienced in supplying one stop service for globe market access such as NMPA, FDA, CE-MDR, CE-IVDR, CMDCAS, ANVISA, Biocompatibility/ISO 10993 Testing. Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation.


Our Services At A Glance:

We offer a rang of testing and certification solutions for All medical devices including emerging technologies and devices such as MedTech, HealthTech, BioTech, AthleticTech and Wareables.

Moreover, our team of experts with years of experience are able to provide full-service testing and certification solutions for wireless medical devices like remote patient monitoring devices. Our medical device solutions cover a wide range of aspects from the design and development stages through manufacturing and end products. 


Product We Test :

1. Active Products

2. Non-active Products

 





(Learn more ⬇⬇⬇)

For example:

1.  Diagnostic Equipment Testing

2. Treatment Equipment Testing

3. Surface Contact Apparatus Testing

4. External Access Device Testing

5. Personal Protective Equipment Testing

6. Bioburden Testing

7.........

(Learn more ⬇⬇⬇)


Why Choose Us?

HTW Lab, accredited by CNAS, CMA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. Our lab meets the requirements of GLP. We can supply test service in accordance with national and global standards for both active and non-active medical products. Our familiarity with these standards makes for a seamless and trustworthy testing process, and a full range of biocompatibility testing capability according to ISO 10993 .

Thus, testing reports from HTW Lab can be accepted between countries.


Your Benefits At A Glance:

1.20 Years Of Experience

HTW has extensive experience in all types of Medical devices and regulatory requirements across markets. 

2.Provide Free Modification Service Program

Together with our wealth of knowledge in complex regulations globally, HTW provides a complete suite of testing solutions according to your needs including free Modification service.

3.Save time to global markets

With over 7,000 square meters of labs, HTW offers the best testing cycles and you don't have to wait in line, HTW offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, HTW can optimize your costs and minimize your time to market.

4.Complete qualifications

ISO/IEC 17025 lab, accreditated by CNAS, CMA,A2LA,GLP.

5.Competitve price

located in China ,Testing costs are lower than other labs.


We're Here for You

We're based in China but regularly work with clients globally. We will get back to you in 1 working day.


Our Business Hours: 

8.30am - 5.00pm in CST (UTC/GMT+08:00) Monday - Friday 


Email:

sales@htwlab.com

Kindly tell us ‘how did you hear about us’.

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HTW Testing and Certification Solutions.

What is Medical Device Registration and Listing


FDA Registration: medical device manufacturers registered with FDA

FDA Listing: medical devices listed with FDA

Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA. Contact us to learn more about FDA Registration Fees.


Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires a premarket submission before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE).


Registration and listing provide the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies. 

Product We Test

Active Products

1. Diagnostic equipment

Physical Diagnostic Kits 

Thermometer, Blood Pressure, Microscope, Audiometer, Various Physiological Recorders, Etc.

Medical Image

X-ray, Ct Scan, Mri, B-scan Ultrasonography

Analytical Instruments

All Types Of Counter, Biochemical, Immune Analysis Instruments, Etc.

Electrophysiology

Electrocardiogram, Electroencephalograph, Electromyograph, Etc.

2. Treatment Equipment

Common Surgical Instruments

/

Optical Surgical Instruments

Fiber Endoscope, Laser Therapeutic Apparatus, Etc.

Auxiliary Surgical Instruments

Anesthesia Machines, Respirator, Extracorporeal Circulation, Etc.

Radiotherapy Machinery

Deep X-ray Therapeutic Apparatus, Cobalt-60 Therapeutic Apparatus, Accelerator, Gamma Knife, Isotope Therapeutic Apparatus, Etc.

Others

Microwave, Hyperbaric Oxygen, Etc.

Non-active Products

1. Surface Contact Apparatus

Electrodes, External Prosthetics, Straps, Compression Bandages And Monitors;

Contact Lenses, Catheters, Intravaginal Or Gastrointestinal Instruments;

Nursing Apparatus And Sealing Applicator;

2. External Access Device

Blood Transfusion, Infusion Set, Extender, Transfer Device, Etc;

Endoscope, Drainage System, Dental Filling Materials, Etc;

Intravascular Catheters, Temporary Pacing Electrodes, Dialyzers, Dialysis Tubes And Accessories, Vascular Adsorbents, Immune Adsorbents, Etc.

3. Personal Protective Equipment

Medical Masks, Medical Protective Clothing, Medical Gloves, Medical Goggles, Melt-blown Cloth, Etc

4. Implanted Devices

Orthopaedic Nails, Artificial Joints, Bone Prostheses, Bone Cement And Intraosseous Devices, Pacemakers, Implantable Drug Delivery Devices, Neuromuscular Sensors And Stimulators, Artificial Tendons, Breast Implants, Artificial Larynx, Subperiosteal Implants, Ligation Clips, Etc

Service Procedure

1. Provide us with product pictures, product brochures/manuals

2. Determine your needs(test report purpose/target market)

3. Receive the testing/compliance service proposal and quotation 

4. Sign contract and make payment

5.Send samples (please contact us for address info.)

6.Informed project opening and test TAT(turn around time) via email

7.Testing 

8.Draft report for your confirmation

9. Formal reports endorsed by ILAC - CNAS (electronic version) 

10.Sample Discard or Return

Other Testing and Certification

FDA 510k

FDA Certification

Patient Monitoring Devices Testing

Wireless Medical Device Testing

Cardiovascular Device Testing

Orthopedic Implant Testing

Mechanical Testing of Materials in Devices and Packaging

Chemical Analysis for Medical Device Components

Biocompatibility Testing for Medical Device

Medical Device Packaging Validation

Healthcare and Medical Testing Services

Class I, II, and III Medical Devices Testing and Certification

Biological Evaluation Of Medical Devices

Personal Protective Equipment (PPE) Testing

Radio Frequency Testing

EMI & EMC Testing

ISO 10993 Biocompatibility Testing

Medical Device Materials Testing

Biocompatibility Testing for Dental Materials


Physical Testing of Medical Devices and IVD Equipment

Electrical Safety Testing (IEC 60601-1)

EMC Testing for Medical Devices

Environmental Testing

Functional Safety Testing of Medical Devices 

IECEE CB Scheme

Wireless Testing for Medical Devices

Ultrasound Testing

In Vitro Diagnostic Medical Devices Testing

Sample Requirements

Pls prepare the samples after our verification.

The samples should be provided safely with standard shipping status. Please provide the samples with sterile barrier packaging if the product is planned to sell under sterile conditions. Have a question about product testing and certification? If possible, kindly tell us ‘how did you hear about us’.

Email us at sales@htwlab.com

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HTW Lab
Product Testing and Certification

Call: 86-0755-26748009

Email: sales@htwlab.com


"Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation"

Address: 1/F, Bldg5, Hongfa Hi-tech Industrial Park, Tianliao, Guangming, Shenzhen City, Guangdong Province, P.R. China 

ISO/IEC 17025 Accredited. 
CNAS.

ILAC.
GLP Laboratory.
CMA.
A2LA.

CBTL.