Medical Device Testing

Medical devices are an integral part of the health care field, but there may be potential adverse risks. FDA, NMPA and other regulatory agencies carry out classified management policies for medical devices according to their risk degree and intended use.

According to FDA regulations, Class Ⅰ devices pose the lowest risk, and their safety and effectiveness can be determined with the use of ordinary controls. However, for most of the high-risk Class Ⅱ and the high-risk Class Ⅲ medical devices, their application materials usually need to include performance data or clinical trial results to ensure the safety of clinical subjects and consumers after the product is marketed.

About Us

We strictly follow regulations to provide reliable medical device compliance testing services, according to customer needs, and to carry out targeted research work.

Our company provides a full range of science-based regulatory compliance solutions for the medical device industry, including product quality assessment services related to registration. We provide professional medical device products and raw materials testing services for medical device manufacturers. Our service capabilities cover biocompatibility and safety evaluation, microbial testing, packaging verification, physical and chemical properties, etc.

• Medical Device Biocompatibility Testing

Our company offers biocompatibility testing services for medical devices, which are used to help manufacturers study how medical devices interact with patient tissues and physiological systems to ensure that patients do not receive negative effects.

• Medical Device Microbiological Testing

We conduct a range of microbiological tests to assess the risk of microbial contamination of medical devices, as required by medical device safety regulations.

• Medical Device Chemical Characterization

We assess the chemical safety of medical devices using advanced analysis, identification and quantification of chemical extractables and leachables in medical devices.

• Medical Device Packaging Testing

We provide validation and performance testing services for medical device packaging in compliance with relevant ISO regulatory requirements. Our services are designed to help manufacturers demonstrate that their packaging ensures the safety and efficacy of the contents prior to use.

Why choose Proregulations?

• We have extensive experience in various types of medical devices, as well as medical device compliance projects in several major countries around the world.
• Our testing services comply with Good Laboratory Practice (GLP), ensuring the accuracy and reliability of the results.
• We have assembled a technical team with the technical, clinical, and regulatory expertise needed to comprehensively evaluate medical device test results.
• We effectively integrate and utilize useful resources, with the advantages of specialization and efficiency.
• We maintain good relationships with various regulatory agencies and are well versed in the submission requirements for medical device registration.

Proregulations is committed to providing comprehensive medical device testing solutions required under the global authoritative regulatory framework. As a medical device regulatory compliance expert, our company ensures that our clients' device test data meets all regulatory requirements and minimizes risk. Through our industry-leading GLP laboratories, we provide efficient, complete, and traceable data and produce compliant medical device quality and performance reports to meet the testing needs of manufacturers of all sizes.

If you need help or have a question, please feel free to contact us for more details.