Kandih Bioscience

Understanding the Building Blocks of a Biologic Effect Report (BER) A Biologic Effect Report (BER) is a cornerstone document in regulatory submissions. Here’s what makes it vital: Key Components of a BER: Study Objectives: Defining the purpose and scope of biologic evaluations. Methodology: Detailed descriptions of the tests and protocols used. Results & Findings: A comprehensive presentation of data collected. Risk Assessments: Interpretation of data for potential human health impacts. Compliance Summary: How findings align with regulatory standards. Why Does It Matter? A well-prepared BER ensures: -Streamlined communication with regulatory bodies. -Demonstration of product safety and efficacy. -Accelerated approval timelines, bringing innovations to market faster. At Kandih Bioscience, we specialize in navigating complex regulatory landscapes. Partner with us for expert guidance in toxicology and drug development. Have questions about BERs? Let’s connect!

From Plan to Report: The Journey of Biological Evaluation Did you know that the biological evaluation process doesn't end with the plan? It culminates in a Biological Evaluation Report (BER)—a critical document that consolidates the findings of your entire evaluation process. The BER ties together test results, risk assessments, and expert evaluations to demonstrate the safety and compliance of your medical device. It should include: - A summary of your BEP - Detailed test results (e.g., cytotoxicity, sensitization, irritation) - Risk assessment outcomes and mitigation strategies - Final expert conclusions A well-prepared BER is your passport to regulatory approval and market entry success! At Kandih Bioscience, we guide you through every step of this journey—from planning to a compliant and robust report. Have questions about the BER process? Let’s discuss in the comments or connect with us to learn more!

Dear Valued Partners and Friends,  As we celebrate this season of giving and reflection, we at Kandih Bioscience extend our heartfelt gratitude for your trust, collaboration, and support throughout the year.  May this holiday season bring warmth to your hearts, joy to your homes, and success to your endeavors. Here's to a bright and prosperous new year, filled with continued partnerships and shared achievements.  🎄 Merry Christmas and Happy New Year! 🎄  With best wishes,   The Kandih Bioscience Team

Have you considered how a biological evaluation might impact your device's market entry? Ensuring that your medical device is biologically safe isn't just a regulatory checkbox—it’s a critical step for market approval and patient trust. A well-structured Biological Evaluation Plan (BEP) not only addresses key safety concerns like cytotoxicity, sensitization, and systemic toxicity but also demonstrates your commitment to compliance and quality. At Kandih Bioscience, we specialize in guiding you through this complex process. From identifying the right tests to navigating ISO 10993 requirements, we’re here to support your journey to market success. Ready to discuss your biological evaluation needs? Let’s connect!

Visualizing the Biological Evaluation Process in Action Imagine a cutting-edge catheter designed to reduce patient discomfort and improve healing. The biological evaluation process starts with identifying risks like cytotoxicity, sensitization, or irritation due to prolonged body contact. Scientists then conduct standardized tests, such as ISO 10993-5 (cytotoxicity), to ensure the material doesn't harm cells, followed by irritation tests using animal models under ISO 10993-10. Once testing confirms safety, the results are integrated into a risk management report, providing confidence to regulators and end-users. This comprehensive evaluation safeguards patient health and accelerates market approval. Curious about how this approach applies to your device? Let's talk!

What does the biological evaluation process look like in action? Let's explore a real-world example. Imagine a company developing a cutting-edge orthopedic implant. To ensure market approval, they executed a thorough biological evaluation plan (BEP), which focuses on the below Cytotoxicity Testing Sensitization Testing Irritation or Intracutaneous Reactivity Testing Systemic Toxicity Testing (Acute, Subacute, Subchronic, Chronic) Genotoxicity Testing Implantation Testing Hemocompatibility Testing Pyrogenicity Testing Biodegradation Testing Carcinogenicity Testing Reproductive and Developmental Toxicity Testing Chronic Toxicity Testing Extractable and Leachable Studies Chemical Characterization (Material Safety) Residual Toxicity or Sterilization Residue Testing The result? A successful regulatory submission and expedited approval, thanks to their compliance with ISO 10993-1 standards. Learn more about the biological evaluation process here: https://lnkd.in/gWWq7esa At Kandih Bioscience, we make complex evaluations simple and effective. Let’s guide you through every step of the process so that you can choose the path that best suits you.

Have you considered how a robust biological evaluation could be the difference between a smooth market entry and delays for your medical device? Learn from a real-world case study where a medical device manufacturer updated their biological safety evaluation to comply with new regulations, ensuring continued market access and patient safety. Dive into the full story here: https://lnkd.in/d--wV9vm At Kandih Bioscience, we specialize in helping innovators navigate these critical evaluations. Let's accelerate your path to market success!

Are you passionate about health, science, and making a difference? The NIH Clinical Center Summer Internship Program offers a unique opportunity for students to gain hands-on experience alongside world-class research scientists and health professionals. Attend our WEBINAR on DEC 12 for more information! https://lnkd.in/g4BescSB About the Program: Paid internship with approximately 40 students selected annually; Program dates: June 16–August 8, 2025. For program information visit: https://lnkd.in/e6Ms6cm5

Did you know? Cutting-edge innovations in medical devices often begin with a robust biological evaluation plan. Take for instance: 1.Keck School of Medicine of USC & Caltech developed smart bandages capable of monitoring chronic wounds, detecting infections, and delivering treatments like electrical stimulation and controlled drug release. Learn more about this groundbreaking solution here. https://lnkd.in/epcUBxEv 2.Universiti Teknologi Malaysia’s CeLLaKCare Patch accelerates healing for hyperglycemic wounds with a sustainable biomaterial derived from rice husks. This eco-friendly innovation highlights the importance of biological evaluations in designing devices for diabetic foot ulcers. Discover details here. https://lnkd.in/ekgrJmNk These examples show how evaluating biocompatibility and mitigating risks lead to safe, effective medical solutions. Want to design your next innovation with confidence? Kandih Bioscience is here to help. Let’s make it happen!

Are you passionate about health, science, and making a difference? The NIH Clinical Center Summer Internship Program offers a unique opportunity for students to gain hands-on experience alongside world-class research scientists and health professionals. Attend our WEBINAR on DEC 12 for more information! https://lnkd.in/g4BescSB About the Program: Paid internship with approximately 40 students selected annually; Program dates: June 16–August 8, 2025. For program information visit: https://lnkd.in/e6Ms6cm5