Welcome to Biocomp Breisgau
The biological safety of medical devices is a fundamental requirement and part of the Design Verification. Navigating the regulatory landscape for biocompatibility and toxicology is a key aspect of product development.
Inadequate material selection or documentation can affect your timeline for market approval and create potential safety risks. Many companies struggle to understand and meet the complex requirements of the EU-MDR and other international standards, which ties up valuable resources and time.
This is where I come in: My expertise helps you minimize these risks and pave a clear path to market authorization. I support you in confidently addressing regulatory challenges and efficiently managing the development process.
Let’s discuss your challenges. Contact me today to schedule a no-obligation initial consultation.
My Profile - Dr. Adrianna Kolberg Founder of Biocomp Breisgau
I am a passionate Subject Matter Expert in the biological safety of medical devices, specializing in biocompatibility and toxicology. I founded Biocomp Breisgau to leverage my extensive experience in the medical device industry and provide expert guidance to companies navigating this complex field.
My expertise is built on a foundation of both practical industry experience and specialized academic training. I am dedicated to serving as a reliable partner for companies looking to ensure the safety and regulatory success of their medical devices.
Regulatory Submissions
I prepared critical reports for submissions, including Biological Safety Assessments and Toxicological Risk Assessments for medical devices worldwide. My specific expertise lies in strategically grouping devices to efficiently meet EU-MDR requirements with a minimized testing effort.
Research & Development:
I have led new product innovation projects and provided expert guidance on material selection, manufacturing process optimization, and ensuring compliance with regulations like ISO 10993, REACH, RoHS, and TSCA.
Standards & Compliance
As a participant in technical standards committees, I stay on the cutting edge of regulatory changes to ensure my guidance is always current and compliant.
Specialized Knowledge:
My academic background includes a PhD in Polymer- Physics, a Master in (Analytical) Chemistry and a degree in Toxicology, giving me the unique ability to address the intricate relationship between materials and biological systems.
My Expertise in Biological Safety Consulting
I specialize in helping you navigate the complexities of medical device biological safety by providing expert guidance in biocompatibility and toxicology. My goal is to ensure your device meets all regulatory requirements and is safe for its intended use - based on pragmatic and cost-efficient approaches.
My services include:
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Evaluating Biocompatibility
I assess the biocompatibility of your new device to ensure its safety and compliance with regulatory standards such as ISO 10993 and FDA guidance.
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Toxicological Assessments
I generate comprehensive toxicological reports in accordance with ISO 10993-17, based on E&L profiles or material data sheets.
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Assessing Design Changes
Changes: I evaluate the impact of design changes or new manufacturing processes on your device's safety profile and provide support with test strategies.
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"Worst-Case"-Product Identification
I identify representative devices for testing, which allows you to minimize your testing efforts and costs while ensuring compliance.
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Regulatory Support
I provide support for your regulatory submissions and audits, including participating in calls and addressing questions from Notified Bodies.
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Gap Analyses
I conduct gap analyses of your existing biocompatibility dossiers and develop tailored test strategies to address any deficiencies.
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Training and Workshops
I offer customized training and workshops for your employees on topics such as biocompatibility (ISO 10993), toxicological assessments (ISO 10993-17), and related regulatory requirements.
My Approach
My process begins with a detailed analysis of your medical device. I first categorize the device and meticulously review all available physical and chemical information. This initial evaluation helps me determine the necessary next steps.
SIf chemical information is insufficient, I will recommend performing a chemical characterization in accordance with the current ISO 10993-18 standard.
Based on these results, I conduct a thorough review of toxicological databases and scientific literature. Often, this research provides enough information to satisfy regulatory requirements, significantly reducing or even eliminating the need for further biological testing.
When additional testing is required, I manage the entire process. This includes planning and overseeing laboratory studies at a facility of your or my choosing. My oversight ensures the results are accurate, reliable, and compliant with all relevant standards and guidelines.
Upon completion of all studies, I prepare a final report. This document includes a toxicological risk assessment aligned with ISO 10993 and ISO 14971, a discussion and evaluation of all results, and a clear, conclusive summary regarding the device's biological safety.
With this approach, tests are only conducted when there's a specific need, rather than being a predefined part of the process. It is a pragmatic, cost-efficient and evidence-based method that systematically reduces your costs and accelerates your time to market by only performing the work that is absolutely essential for regulatory compliance.
