Medicinal and Biologics Medical Devices

Medicinal and Biologics Medical Devices are specialized categories within the broader spectrum of Medical Devices, including drug-eluting implants, pre-filled syringes, biologics delivery systems, and medicated devices. These combination productscombine the intricacies of pharmaceuticals with the precision of medical engineering. At Meditronics (a brand of STEMart), we offer comprehensive testing services tailored specifically for Medicinal and Biologics Medical Devices. Our state-of-the-art facilities, combined with our team of experienced professionals, ensure that your devices meet the highest standards of quality and regulatory compliance. Our expertise spans across various testing domains, making us a one-stop solution for all your testing needs.

Our Service

The MDR categorises various medicinal and biologics medical devices, including drug-device combinations, products with ancillary medicinal substances or human blood derivatives, devices using human/animal tissues or cells, substance-based devices, and ART/IVF devices. Each category has specific rules and assessment processes. Our testing services cover a wide range of critical areas, including biocompatibility, materials characterization, microbiological and virological testing, shelf-life testing, and validation of cleaning, reprocessing, and sterilization processes. Additionally, we specialize in ADME (Absorption, Distribution, Metabolism, and Excretion) testing for drug components within these devices, ensuring that the pharmaceutical aspects of your devices meet the highest standards of safety and efficacy.

• Biocompatibility Testing

We perform comprehensive biological safety evaluations including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and implantation studies. Our assessments utilize both in vitro and in vivo models to evaluate tissue compatibility, with specialized protocols for combination products containing biologics or pharmaceuticals.

• Material Characterization

Our laboratories conduct complete material analysis including physicochemical property testing and extractables/leachables studies. Using advanced analytical techniques, we identify and quantify residual solvents, elemental impurities, and degradation products.

• Microbiological Testing

Our sterility assurance program includes bioburden testing, sterilization validation, and bacterial endotoxin detection. We perform viral clearance studies for biologics containers and employ multiple methodologies for container closure integrity testing.

• Performance & Stability

We conduct dose accuracy studies for autoinjectors and wear simulation for implants. Stability testing features real-time and accelerated aging studies with comprehensive container integrity monitoring throughout the product lifecycle.

• ADME/PK Studies

For combination products contain drugs, we perform absorption, distribution, metabolism, and excretion evaluations. Our pharmacokinetic assessments include drug release kinetics, tissue distribution studies, and metabolite identification. Transdermal systems undergo specialized permeation and release testing.

Why Choose Meditronics?

• PhD-level scientists with dual expertise in pharmaceuticals and medical devices
• Integrated testing for both device functionality and drug compatibility
• One-stop solution covering all regulatory requirements
• Flexible testing protocols tailored to product specifics

At Meditronics, we combine cutting-edge technology, regulatory expertise, and scientific excellence to deliver reliable testing solutions for medical devices. Our comprehensive services—from biocompatibility and material characterization to sterilization validation and ADME/PK studies—ensure your products meet global compliance standards while accelerating time-to-market. Contact our testing specialists today to schedule your program assessment.