MEDICAL DEVICES
At Medbotics LLP we offer comprehensive biocompatibility assessment solutions designed to meet the rigorous standards of ISO 10993 guidelines and the US FDA’s modified ISO matrix. Our team possesses extensive experience in handling a wide range of medical devices. Leveraging our expertise in pharmaceutical services and regulatory support, we can tailor a biocompatibility testing program that seamlessly integrates with your product development and commercialization goals.
SCS ADHERES TO THE FOLLOWING ISO 10993 GUIDELINES (INCLUDING THE FDA'S VERSION #G95-1)
| Code # | Study Title |
|---|---|
| 10993-1 | Guidance on Selection of Tests |
| 10993-2 | Animal Welfare Requirements |
| 10993-3 | Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity |
| 10993-4 | Selection of Tests for Interactions with Blood |
| 10993-5 | Tests for Cytotoxicity-In Vitro Methods |
| 10993-6 | Tests for Local Effects after Implantation |
| 10993-7 | Ethylene Oxide Sterilization Residuals |
| 10993-9 | Degradation of Materials Related to Biological Testing |
| 10993-10 | Tests for Irritation and Sensitization |
| 10993-11 | Tests for Systemic Toxicity |
| 10993-14 | Materials Evaluation |
MEDICAL DEVICE TESTING - ENSURE MEDICAL DEVICE SAFETY & COMPLIANCE
At Medbotics LLP, we offer a one-stop solution for medical device testing, helping you achieve market access with confidence. Our services are designed to meet the needs of both small and large-scale manufacturers, ensuring the highest quality data and regulatory compliance.
OUR TEAM
- Experienced chemists, veterinarians, scientists, toxicologists, and regulatory affairs consultants.
- Deep understanding of technical, pre-clinical, and regulatory aspects of medical device testing.
BIOCOMPATIBILITY TESTING SERVICES
ISO 10993 Compliance: Assess the biological safety of your device according to international standards.
- Cytotoxicity, Genotoxicity, Hemocompatibility: Evaluate potential cell damage, genetic effects, and blood compatibility.
- Irritation, Sensitization: Identify potential skin irritation and allergic reactions.
- Systemic Effects, Pyrogenicity, Implantation: Test for systemic toxicity, fever induction, and long-term implantation effects.
- Toxicological Risk Assessment: Gain a comprehensive understanding of potential device-related risks.
CHEMICAL CHARACTERIZATION SERVICES
- ISO Standards: Ensure compliance with relevant ISO standards for chemical characterization.
- Material Characterization: Identify and quantify the components of your device materials.
- Degradation Products: Assess the breakdown products of your device over time.
- Tolerable Intake: Determine the safe levels of extractable substances from your device.
- Ethylene Oxide Residuals: Evaluate residual levels after sterilization with ethylene oxide.
PARTNER WITH MEDBOTICS LLP FOR
- State-of-the-art testing facilities: Leverage our partner labs which are OECD GLP, NABL and ISO 17025 Certified, equipped with advanced equipment for accurate results.
- End-to-end support:We guide you through the entire testing process, meeting project deadlines efficiently.
- Regulatory expertise: Our team helps navigate complex regulatory requirements globally.
Contact Medbotics LLP today to ensure the safety and market readiness of your medical device.
STRATEGIC OUTSOURCING AND EXPERT PROJECT MANAGEMENT
Accelerate Research with Expert Outsourcing Solutions from Medbotics LLP
In today’s dynamic research landscape, staying ahead requires embracing new technologies and forging strategic partnerships. Outsourcing specific research tasks allows you to:
BENEFITS OF OUTSOURCING WITH MEDBOTICS LLP
- Expert Collaboration: Partner with highly reputable Contract Research Organizations (CROs) for reliable data and project completion.
- Tailored Solutions: We design customized studies to meet your specific project needs and objectives.
- Gold-Standard Management: Our experienced team oversees the entire outsourcing process, ensuring timely delivery and cost-effectiveness.
- Transparency & Collaboration: We maintain open communication throughout the project, keeping you informed and involved at every step.
OUR COMPREHENSIVE OUTSOURCING SERVICES
- Pre-validated Disease Models: Access a library of validated disease models to expedite your research.
- Robust In Vivo Experiments: Our CRO partners leverage advanced techniques and highly skilled personnel for reliable in vivo studies.
- Pathological Services: We offer comprehensive pathology services, including tissue processing, slide preparation, and histopathological analysis.
- Contract Archives Facilities: Securely store your research materials at GLP-compliant contract archives facilities.
Services we have for MEDICAL DEVICES
Our Motto
Our ‘Client First’ motto drives us to prioritise regulatory challenges which allow both flexibility for the client and compliance to be a reference of excellence in the global supply of solutions for validation in order to enable regulatory compliance for companies of all sizes.
Vision
Following the best regulatory practices combining our expertise & experience with client’s insights
Mission
To deliver tangible and sustainable results to the clients by innovative proposals, digital transformation, information security and sustainability.
Medbotics LLP