Biocompatibility evaluation is a critical regulatory requirement for ensuring that medical devices are safe for patient use. ACCUPREC provides comprehensive biocompatibility testing in accordance with ISO 10993 series requirements.

Benefits:

• Global regulatory acceptance
• Compliance with ISO 10993 standards
• Reliable data for regulatory submissions
• Faster market approval pathways

Our Capabilities Include:

• Cytotoxicity Testing
• Skin Sensitization Studies
• Irritation & Intracutaneous Reactivity
• Acute Systemic Toxicity
• Subacute & Subchronic Toxicity
• Implantation Studies
• Hemocompatibility Testing
• Genotoxicity Assessment
• Material Characterization Support

Understanding potential chemical risks associated with medical devices, packaging systems and pharmaceutical products is essential for patient safety and regulatory compliance. ACCUPREC offers end-to-end support for Extractables & Leachables (E&L) studies and Toxicological Risk Assessments.

Applications:

• Medical Devices
• Drug Delivery Systems
• Pharmaceutical Packaging
• Combination Products
• Polymer-Based Products

Our multidisciplinary team combines analytical science and toxicology expertise to provide scientifically justified risk assessments aligned with global regulatory expectations.

Services Include:

• Extractable Studies
• Leachable Studies
• Chemical Characterization
• Compound Identification
• Toxicological Risk Assessment (TRA)
• Safety Threshold Evaluation
• Regulatory Gap Analysis
• Expert Toxicological Reporting

Product stability directly impacts quality, safety and performance throughout the product lifecycle. ACCUPREC provides stability and transportation simulation studies designed to evaluate product integrity under various environmental conditions.

Advantages:

• Regulatory-compliant stability data
• Improved product reliability
• Reduced transportation risks
• Enhanced supply chain confidence

Testing Services:

• Accelerated Stability Studies
• Real-Time Stability Studies
• Temperature & Humidity Exposure
• Shelf-Life Determination
• Transportation Simulation Testing
• Packaging Integrity Assessment
• Environmental Stress Testing

Packaging plays a critical role in protecting pharmaceutical products and medical devices throughout storage, transportation and usage. Our packaging and mechanical testing services help manufacturers verify product durability, performance and compliance.

Industries Served:

• Medical Devices
• Pharmaceutical Packaging
• Sterile Barrier Systems
• Combination Products
• Consumer Healthcare Products

Testing Capabilities:

• Compression Testing
• Burst Strength Testing
• Seal Integrity Testing
• Tensile Strength Testing
• Peel Strength Evaluation
• Vibration Testing
• Drop Testing
• Package Validation Studies

A Clinical Evaluation Report (CER) is a fundamental requirement for demonstrating the safety and clinical performance of medical devices. ACCUPREC supports manufacturers in preparing scientifically robust CERs that align with international regulatory requirements.

Regulatory Alignment:

• MDR Requirements
• MEDDEV Guidelines
• ISO 14155 Considerations
• Global Regulatory Expectations

Benefits:

• Improved regulatory readiness
• Stronger submission documentation
• Efficient approval processes
• Expert scientific support

Our CER Services Include:

• Literature Review & Analysis
• Clinical Data Evaluation
• Risk-Benefit Assessment
• Clinical Evidence Gap Analysis
• State-of-the-Art Review
• Post-Market Clinical Data Assessment
• CER Preparation & Updates

Microbiological testing is essential for ensuring product quality, sterility and patient safety. ACCUPREC provides a wide range of microbiological testing services for pharmaceuticals, medical devices and healthcare products.

Why It Matters:

• Ensures product safety
• Supports regulatory compliance
• Maintains manufacturing quality standards
• Reduces contamination risks

Testing Services:

• Sterility Testing
• Microbial Limit Testing
• Bioburden Determination
• Bacterial Endotoxin Testing
• Antimicrobial Effectiveness Testing
• Environmental Monitoring
• Water Testing
• Cleanroom Monitoring