Medical Device And Healthcare

Medical Device Biocompatibility Overview

The medical device division at BRF is a dedicated and advanced facility that offers a comprehensive range of services to support the development and testing of medical devices. We understand the unique regulatory requirements and technical challenges associated with medical devices, and our experienced team is committed to providing high-quality and reliable solutions to our clients.

One of the key strengths of our medical device division is our state-of-the-art laboratory, equipped with cutting-edge equipment and technologies. This allows us to conduct a wide range of tests and evaluations to ensure the safety, efficacy, and compliance of medical devices across various classes.

Biocompatibility Testing:

Our expertise in medical device testing covers several critical areas. Bio-compatibility testing is an essential component to assess the compatibility of medical devices with biological systems. We conduct various biocompatibility tests, including cytotoxicity, sensitization, irritation, and systemic toxicity evaluations, in accordance with international standards such as ISO 10993.

Hemo-compatibility testing is another crucial aspect of medical device evaluation, particularly for devices that come into contact with blood. We offer a comprehensive suite of hemo-compatibility tests, including hemolysis, coagulation, platelet activation, and complement activation assays, to ensure the safety and performance of blood-contacting medical devices.

Reprocessing studies are vital to assess the ability of reusable medical devices to withstand cleaning, sterilization, and disinfection processes without compromising their functionality or safety. Our facility is well-equipped to perform reprocessing studies according to established protocols, evaluating the device’s integrity, material compatibility, and microbial contamination.

Sterilization validation is a critical step in the development of sterile medical devices. We offer a range of sterilization validation services, including ethylene oxide (EO) sterilization, and steam sterilization studies. These tests evaluate the efficacy of sterilization processes and ensure that the device remains sterile throughout its intended shelf life.

Functional testing is an essential component of medical device evaluation, focusing on the device’s intended use, performance, and reliability. Our facility is equipped with advanced equipment and specialized testing setups to assess the functional aspects of medical devices accurately. This includes mechanical testing, performance testing, and usability evaluations.

In addition to the above-mentioned services, we offer xenograft testing for medical devices that involve interaction with living tissues or organs. This testing assesses the compatibility, functionality, and safety of the device within a living organism, providing valuable insights into its performance and potential clinical applications.

At BRF, we understand the importance of regulatory compliance in the medical device industry. Our testing services are conducted in accordance with relevant international standards, such as ISO and FDA guidelines. We adhere to Good Laboratory Practices (GLP) and maintain a robust quality management system to ensure the accuracy, reliability, and traceability of our results.

With our comprehensive range of testing services, state-of-the-art facilities, and experienced team of experts, BRF is committed to supporting the development and evaluation of safe and effective medical devices. We strive to be a trusted partner for our clients, providing reliable data and valuable insights to facilitate regulatory approvals and enhance patient safety.

Our Lab

Services Offered

Biocompatibility Testing

 

  • Cytotoxicity testing
  • Sensitization testing
  • Irritation and intracutaneous reactivity testing
  • Systemic toxicity testing
  • Genotoxicity testing
  • Implantation testing ( Rodents, Rabbits, Mini-Pigs etc)
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Sterility Testing
  • Sterility assurance testing
  • Microbial limits testing
  • Bacterial endotoxin testing
  • Bioburden determination
  • Sterilization process validation
Shelf-Life Determination
  • Accelerated aging studies
  • Stability testing
  • Package integrity testing
  • Material degradation analysis
  • Environmental testing (temperature, humidity)
Mechanical Testing and Performance Evaluation
  • Tensile strength and elongation testing
  • Compression testing
  • Flexibility and fatigue testing
  • Wear and friction testing
  • Load and stress testing
  • Biomechanical testing
Packaging and Labeling Evaluation
  • Package integrity testing
  • Labeling verification and validation
  • Shelf-life assessment of packaged products
  • Environmental impact analysis (recyclability, sustainability)