INDUSTRIES
Medical Devices
Ensure the safety and efficacy of your medical devices with 1LAB’s comprehensive preclinical testing solutions
We offer an extensive suite of in vitro tests tailored specifically for medical devices. Our comprehensive evaluations cover various facets, from assessing the adhesive properties on mucous membranes to understanding pro-proliferative effects on cell lines.
We delve into recovery, protection, and antioxidant capabilities, ensuring products meet stringent criteria for regulatory purposes. Our solutions ensure that your devices meet rigorous safety and efficacy standards, providing valuable insights throughout your product development cycle.
Medical Devices safety test overview
We adhere to international regulations, including ISO 10993, offering tests designed to assess the biocompatibility and performance of your medical devices.
Cytotoxicity
In-depth evaluation of cell viability in compliance with ISO 10993-5:2009 + ISO 10993-12:2021.
Irritation
Skin irritation testing in line with ISO 10993-23 :2020 + ISO 10993-12:2021, crucial for product safety and regulatory compliance.
Sensitization
Evaluation of potential allergic responses using ISO 10993-10:2021 + ISO 10993-12:2021, ensuring patient safety and product reliability.
Medical Devices efficacy
In Vitro test overview
- Mucoadhesive properties
- Pro-proliferation
- Recovery properties
- Protection properties
- Antioxidant activity
- Radical scavenging activity
- Absorption evaluation based on OECD 428
- Barrier effect and Tissue permeability assessment
- Antipollution assay
- Anti-aging
- Wound healing/Regenerative properties
- Anti-pigmentation
- Immunomodulant properties for not systemically absorbed products
- Tensile strength assay, mechanical characterization
Why choose 1LAB?
Regulatory Compliance
According to Regulation (EU) 2017/745 requirements and based on ISO 10993.
Comprehensive Analysis
Detailed insights into various aspects of medical devices performances.
Advanced Techniques
Utilization of 3D tissue models for accurate testing.
Expert Team
Dedicated professionals with multidisciplinary scientific backgrounds.
Elevate your medical devices Development Process
Rely on 1LAB's cutting-edge in vitro testing to verify the safety, functionality, and compliance of your medical devices. Work with us to maximize your innovations' potential and bring confidently approved products to market.
