A Rigorous Biological Evaluation Process

RQM+ follows a structured, ISO 10993-based approach to biological evaluations, encompassing every stage from initial risk assessment to detailed regulatory submissions. Our evaluation process includes:

  • Understanding Device Context: We begin by assessing the device’s intended use, material composition, and manufacturing processes. By reviewing existing safety data, we develop a customized approach that aligns with your device’s specific risks and regulatory needs​.
  • Risk Assessment: Our team conducts a thorough risk assessment, focusing on key biocompatibility factors such as duration of exposure and type of body contact, as prescribed by ISO 10993-1:2018. We address both localized and systemic endpoints to ensure comprehensive safety.
  • Data Review and Testing Strategy: We evaluate all existing biological evaluation data to identify any gaps. Based on our findings, we design a precise testing strategy, targeting only the necessary endpoints, and avoiding redundant tests where possible.

 

Comprehensive Biological Endpoint Testing

Biological safety assessment is critical for ensuring that materials are biocompatible and do not pose health risks. RQM+ provides a full suite of biological endpoint tests, including the foundational “Big Three” assessments—cytotoxicity, skin sensitization, and irritation testing—as well as a range of additional evaluations, such as:

  • Hemocompatibility
  • Pyrogenicity
  • Genotoxicity
  • Systemic Toxicity

Our approach integrates in vitro, in vivo, and chemical characterization methods to cover a wide array of biological risks, ensuring thorough evaluation tailored to your product’s specific needs​.

Regulatory Compliance and Global Standards

Ensuring regulatory compliance is at the heart of what we do. RQM+ has a deep understanding of both FDA guidelines and ISO 10993 standards, making us a trusted partner for global regulatory submissions.

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Our team develops comprehensive BEPs aligned with ISO 10993-1, outlining the necessary biological testing and justifying any endpoints that do not require testing.

We conduct thorough chemical analyses to identify potential risks from device materials, supported by our toxicology experts who perform detailed risk assessments based on current scientific guidelines.

By addressing all relevant biological endpoints, we ensure your device meets regulatory expectations for both immediate and long-term safety​.

Customized Protocol Design for Novel Products

At Jordi Labs, an RQM+ company, we excel at developing custom protocols for unique materials and products. With over 40 years of experience in chemical testing and characterization, our PhD-level scientists design testing strategies that maximize efficiency and avoid unnecessary tests. This tailored approach is especially valuable for medical devices and pharmaceutical packaging that incorporate innovative materials​.

We support every stage of product development, from initial R&D through pre-clinical validation and final documentation, ensuring a seamless path to regulatory compliance.

Integrated Biological and Chemical Safety Services

RQM+ offers a comprehensive evaluation approach, integrating biological evaluations with chemical characterization, toxicological risk assessments, and extractables and leachables (E&L) testing. This holistic service ensures that every aspect of chemical and biological safety is addressed, providing your team with a thorough understanding of your product’s safety profile.

By combining these services, RQM+ provides clients with reliable data and actionable insights that streamline the regulatory process and support informed decision-making​.

Why Choose RQM+ for Your Biological Evaluations?

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Our expertise at RQM+ is backed by a team of PhD-level toxicologists and analytical chemists who deliver scientific precision and regulatory insight. We provide custom protocols that meet global standards, ensuring that your product is fully evaluated for both safety and compliance. With a focus on efficiency and accuracy, RQM+ offers comprehensive biological evaluations that accelerate time to market without compromising on safety.

Ensure your device meets the highest biocompatibility standards. Talk to our experts today.

We are passionate about your success. Tell us more about your needs so we can help.

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