Medical Device Testing

Testing and Certification Solutions for All Medical Devices/ IVD Devices

About JJR Laboratory:

JJR 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. Providing biocompatibility testing for various types of medical devices to help manufacturers meet regulatory compliance and achieve global acceptance. For technical regulation support, technicians at JJR 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 a free evaluation and proposal.

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. 

Why Choose Us?

JJR 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 JJR Lab can be accepted between countries.

Your Benefits At A Glance:

1.20 Years of experience

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

2.Provide free modification service

Together with our wealth of knowledge in complex regulations globally, JJR 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, JJR offers the best testing cycles and you don't have to wait in line, JJR offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, JJR 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

Testing costs are lower than other labs

Email:

hello@jjrlab.comYou can also contact us directly by email.

JJR 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

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 hello@JJRlab.com.