Biological evaluation isn’t just about raw materials. ISO 10993-1 emphasizes assessing all risks—from design to manufacturing to final product—within a risk-management framework. Starting this exercise early is key to a less burdensome development path. Similarly, any changes made to an existing marketed device also requires re-evaluation of any new risks. SD Bioscience Services provides the expertise you need to ensure regulatory compliance and success.

• Comprehensive planning – information gathering (intended use, raw material specifications, compliance statements, manufacturing process, packaging and sterilization modality), gap analysis and define smart biocompatibility strategies
• Early considerations in new product development – help with material selection, initial risk assessments
• Support regulatory submissions - US-FDA and other notified body meeting support, address regulatory deficiency
• Life-cycle management - help with design and manufacturing change assessments
• Remediation - EU-MDR and CAPA remediation, help with biocompatibility procedures (SOPs and WIs) in accordance with ISO 10993 for Class I-III medical devices

Inadequate information or lack of clarity in documentation can lead to confusion and multiple regulatory review cycles. It is important to clearly present device details, systematic assessment, reasoning for testing or rationale, test methods, data and its analysis or extrapolation, and conclusions. The ISO 10993-1 standard requires experienced individuals to author biocompatibility documents and SD Bioscience Services can help ensure thorough documentation for your medical device assessment.

• Biological Evaluation Plan (BEP)
• Biological Evaluation Report (BER)
• Biocompatibility Equivalency and Adoption
• Review and/or author test protocols and reports
• Change Assessment: Rationales and justifications

Material and chemical characterization (ISO 10993-18 and -17) are essential first steps in any biocompatibility assessment. These evaluations often require testing through accredited contract research organizations (CROs). Depending on the device’s intended use and existing data, additional biological endpoint testing may be necessary to demonstrate biological safety. Obtaining sufficient data from well-designed tests is critical for establishing safety. SD Bioscience Services offers expert guidance in study design to help you avoid common pitfalls and potential regulatory deficiencies.

• Support screening and selection of CROs
• Extractable & Leachable (E/L) study design
• in-vitro and in-vivo biological endpoint testing study design
• Focused test design (least burdensome) to address change

Cleaning and sterilization validations are critical processes and play important roles in biocompatibility assessment of medical devices. A valid cleaning process not only ensures effective removal or inactivation of contaminants to acceptable levels but also reinforces trust in manufacturing operations conducted within a controlled environment. In addition, cleanliness of a device can impact sterilization effectiveness. While the order of cleaning validation, sterilization validation and biological evaluation may vary, the concepts should be considered as intertwined rather than in isolation. They are essential elements of a robust quality assurance process that ensure the safety and effectiveness of medical devices. SD Bioscience Services can help you with these efforts to demonstrate compliance.

• Reprocessing Cleaning validation for reusable devices
• Manufacturing cleaning validation
• Sterilization validations (EO, Radiation and Steam)
• Microbiology methods