Tailored toxicology and regulatory advisory services.
In Vitro Testing and Pharmaco-Toxicology Expertise
The in vitro testing consultancy service supports customers with high-level testing strategies related to regulatory in vitro toxicology and provide an accurate and ethical approach for hazard identification and risk assessment following the 3Rs principle.
The Pharmaco-Toxicological consultancy services support medical device industries to be compliant with MDR requirements by providing:
- Pharmacology expertise to address product identification and medical device classification, if necessary
- Raw materials’ toxicological characterization and safety assessment according to ISO 10993-1
- Assessment of systemic exposure for the identified use and calculation of safety margins: toxicological expertise on the results of in vitro percutaneous absorption
- Toxicological risk assessment of residual impurities from the manufacturing process (ISO 10993-18), products’ degradation (ISO 10993-13/-14/-15) and substances extracted from the medical device and/or released by the primary packaging (ISO 10993-17) including polymers (plastic/silicon), solvents, elemental and genotoxic impurities and definition of their safety limits
- Biocompatibility test plan strategy development following the 3Rs principle thus avoiding animal testing using alternatives and in silico prediction
- Biological Evaluation Plan and design input within a risk management process in accordance with ISO 14971 and Gap analysis to ISO standards
- Biological Evaluation Report, interpretation of the results obtained in the biocompatibility and the overall biological safety in accordance with ISO 10993-1
Relevant standards:
ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-13:2010 Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-14:2001 Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics
ISO 10993-15:2019 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
ISO 10993-17: 2002 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18: 2018 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
ISO 14971:2019 Medical devices – Application of risk management to medical devices
Regulatory compliance support by ToxHub
The in vitro testing and pharmaco-toxicological consultancy services provide expert advice during product development and/or to respond to regulatory requirements:
- Product identification as medical devices and medical device classification
- Risk identification: GAP analysis, Biological Evaluation Plan (BEP)
- Risk mitigation by in vitro testing
- Evaluation of results: Biological Evaluation Report (BER), toxicological risk assessment and safety margins calculation and biological testing interpretation
