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Biocompatibility Testing

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Medical Device Biocompatibility Testing

Biocompatibility testing is the process of evaluating whether medical devices that come into direct contact with patients such as implants, surgical instruments, tubes, etc. interact safely with the body to ensure they won’t cause harmful side effects in use. During product development, medical devices must undergo stringent biocompatibility testing as part of the regulatory pathway (e.g., FDA, PMDA, MDR).

Medical Device Biocompatibility Testing

 

Lucideon offers end-to-end ISO 10993-compliant biocompatibility support for an extensive range of medical devices. Utilizing our in-house capabilities coupled with our strong partnership network with industry experts, we help manufacturers meet stringent regulatory and safety standards for their products as well as solve complex development challenges to accelerate and optimize the route to market.

Our solutions can support the development of medical devices for a range of regulatory bodies, including but not limited to the FDA, PMDA, and EU bodies such as DEKRA, TUV SUD, etc.

The biocompatibility assessment process:

  1. Develop a biological evaluation plan (BEP)
  2. Perform required analytical tests
  3. Construct a biological evaluation report (BER)

Types of medical devices we support:

  • Orthopaedic implants
  • Surgical tools
  • Tubes and catheters
  • Dental devices (implantables and tools)
  • Combination devices e.g. injectables, inhalation devices, filled IV bags, etc
  • External devices e.g. prosthetics, hearing aids
  • and more

 

 

Chemical characterization testing

Lucideon's team of experts offer comprehensive in-house chemical characterization for biocompatibility assessment (ISO 10993 part 18). This process involves the assessment of substances released from medical devices that fall into 2 categories:

  • Extractables - substances released from the device under exaggerated conditions e.g. high temperature or in the presence of a strong solvent
  • Leachables - substances released from the device under normal conditions

The data obtained from the chemical characterization process is essential to meet the stringent regulatory requirements needed to get your product to market.

Analytical methods we use:

  • HPLC (High-Performance Liquid Chromatography)
  • GC-MS (Gas Chromatography-Mass Spectrometry)
  • LC-MS (Liquid Chromatography-Mass Spectrometry)
  • ICP-MS (Inductively Coupled Plasma-Mass Spectrometry)

 

 

Why choose Lucideon?

Our biocompatibility solutions ensure your medical devices meet stringent regulatory requirements to make the route to market easier. Key benefits of working with Lucideon include:

  • Partnership: At Lucideon we don’t simply provide you with analytical results, we work with you to truly understand the challenge and navigate the complex regulatory pathway
  • Compliance and accuracy: With analytical expertise in commonly used methodologies, Lucideon delivers trusted results recognized by the FDA, MDR, PMDA, and more
  • End-to-end solutions: Lucideon can support the biocompatibility assessment of your product from start to end, making your route to market as easy as possible

Contact us today to learn more about how our biocompatibility testing solutions can support your product development.