Our toxicology and regulatory experts have years of experience in providing guidance and understanding of the steps needed to ensure that medical devices are biocompatible and meet the necessary international standards. Working closely with our clients we will assess the biological and chemical safety needs, carry out risk assessment plans; design, prepare and closely monitor studies in addition to ensuring compliance to regulatory requirements. Our coordinated approach assures our clients that their medical device can be safely used where indicated.
Medical devices require varying degrees of biological safety testing, according to their classification and use, in order to determine that they have appropriate biocompatibility. It consists of material characterisation and various biological and chemical assessments designed to provide assurance that the final product, when used as indicated, will be safe. The main source of guidance on the essential requirements for biological safety are the ISO 10993 series which cover biological evaluation of medical devices.
At ApconiX, biocompatibility and toxicology risk assessment capabilities include:
- Biological risk assessments, evaluation plans, gap analyses and reports, in compliance with ISO 10993-1, ISO 10993-17 and ISO 14971
- The design and preparation of in vivo and in vitro studies related to all biocompatibility development activities, in which ApconiX can act as the single point of contact in the monitoring and coordinating of these outsourced studies
- Toxicological risk assessments and determination of appropriate margins of safety following chemical characterisation testing
In addition, we are able to advise on regulatory pathways and classification for medical devices.
Our Medical Device Experts
Dr Simon Craige
MSc, ERT, DABT
Simon is a European Registered Toxicologist and Diplomate of the American Board of Toxicology with over 15 years of nonclinical and toxicology experience within various pharmaceutical and medical device settings. Simon has worked within biotech and a number of CROs across a diverse range of therapeutic areas in both Discovery and Development. His experience includes a variety of therapeutic platforms including small molecules, biologicals, and medical devices. During his career, he has acted as a single point of contact for the planning and monitoring outsourced studies, interpretation of study results, contingency planning/troubleshooting, report reviewing and authoring of regulatory documents.
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MSc CSci CChem FRSC FTOPRA
Angela has a strong scientific background in chemistry, pharmacology and toxicology and over 30 years of regulatory affairs experience in medicinal product and medical device development. She has extensive experience of ICH, FDA and Committee for Medicinal Products for Human Use (CHMP) guidelines for a wide range of pharmaceutical products, and the International Organization for Standardization (ISO) standards for medical devices, in vitro diagnostics and quality systems. She has been influential in regulatory affairs training and mentoring and is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA) and a Fellow of the Royal Society of Chemistry. Angela was the winner of the 2015 TOPRA Award for Contribution and 2020 TOPRA Award for Inspiration.