Active and Passive Medical Device Testing Services

One-Stop Testing and Certification for All Categories of Medical Devices

Our services cover all categories of Class I, Class II, and Class III active and passive medical devices, spanning across all product sectors including rehabilitation, anesthesia, monitoring, dental, ophthalmic, imaging, consumables, and surgical instruments.

Equipped with complete testing laboratories, professional equipment, and a dedicated team of engineers, we can complete domestic registration testing and FDA/MDR international market access testing. We also provide specialized services such as on-site testing for large-scale equipment and expedited testing to shorten the time-to-market for enterprise products.

Active Medical Device testing Services

• Comprehensive Testing: Safety, EMC (Electromagnetic Compatibility) pre-testing/rectification/site rental, active performance, reliability, environmental testing, and wireless testing.

• Domestic Services: Domestic registration type testing, R&D pre-testing, and packaging & transportation testing.

• International Testing: US FDA and EU MDR supporting registration testing.

• Coverage: Patient monitors, respiratory and anesthesia equipment, first aid, rehabilitation, imaging, medical robots, IVD analyzers, etc.

Passive Medical Device Testing Services

• Comprehensive Testing: Physical and mechanical properties, chemical properties, restricted substances, microbiology, sterility, and cleanroom testing.

• Coverage: Full-item testing for medical consumables, surgical instruments, dental products, ophthalmic optics, implantable consumables, and packaging.

Medical Software Evaluation & Cybersecurity Testing

Cybersecurity Testing

• Cybersecurity for medical electrical equipment

• US FDA cybersecurity compliance testing

• European MDR cybersecurity compliance testing

• Radio equipment cybersecurity

• IoT (Internet of Things) device cybersecurity

• Industrial equipment cybersecurity

Software Evaluation Services

• Medical software registration testing

• Medical imaging software testing

• Quality requirements and evaluation standards testing for artificial intelligence (AI) medical devices

• Software evaluation registration guidance and training

• Cybersecurity compliance training

Service Product Coverage

Our service scope comprehensively covers Class I, Class II, and Class III active and passive medical devices across various fields:

• Physical therapy / Rehabilitation instruments

• Respiratory anesthesia / First aid devices

• Medical software products

• Medical examination / Monitoring instruments

• Oral / Dental products

• Ophthalmic optical products

• Surgical instruments

• Clinical laboratory devices

• Medical imaging devices

• Patient-bearing devices

• Medical robots

• Medical consumables

• Extracorporeal circulation devices

• Full line of medical device packaging

Expedited Testing Services

We offer an exclusive expedited testing channel with priority scheduling by a team of professional engineers, promising to issue the official active medical device testing report within 4-5 weeks. We strictly control testing accuracy and compliance standards throughout the entire process without compromising testing procedures. This significantly shortens the product registration cycle and helps you quickly seize the market access window.

JJR LAB holds dual national-level qualifications of CNAS and CMA and is listed in the national directory of medical device testing institutions, possessing over 800 authorized standard qualifications for medical device testing.

With a laboratory area of over 8,000 square meters, we are equipped with a 10-meter semi-anechoic chamber, microbiological clean laboratories, and a complete set of environmental reliability, electromagnetic compatibility, and physical-chemical microbiology testing equipment, enabling us to complete compliance testing for all categories of medical devices.