Understand the specifics of the chemical characterization process
Understand the specifics of the chemical characterization process
A medical device or material that comes in contact with the patient's body is expected to perform its intended function without resulting in any adverse effect to a patient. Potential adverse effects can range from short-term (acute) to long-term (chronic) adverse effects to the body such as mutagenic effects. For this reason, medical devices are typically subject to biological evaluation and biocompatibility testing to evaluate the interaction between a device and tissue, cells or body fluids of the patient.
Chemical characterisation may be used to identify and quantify chemical substances found in medical devices or materials that may contribute to the toxicological and biological risk management for the device. Conducting a chemical characterisation consistent with the requirements of ISO 10993-18 is a critical aspect of a manufacturer’s overall effort to verify the safety of their medical devices. A thorough evaluation of the chemical safety of device components and materials can increase the likelihood of a smooth and efficient regulatory review process.
To navigate through this, our expert practitioner will be extending his insights through a webinar, covering an elaborate account of requirement of chemical characterization over availability of Biocompatibility studies.
Details:
Date: 2nd November
Day: Thursday
Time: 3:00pm IST
Speaker: Mr. Naresh Kumar Nagula
Agenda:
Who should attend:
Naresh Kumar N – Toxicologist and Biocompatibility expert
Naresh Kumar Nagula is designated as a Toxicologist and Biocompatibility expert at TÜV SÜD South Asia's Medical & Healthcare Services (MHS). He has completed his Masters degree in pharmacology, Hyderabad. He has worked for different organizations and gained experience of spanning over ten years in the field of medical device biocompatibility and toxicology. His professional background includes extensive assignments in the healthcare & allied industries.
He has expertise in medical device biocompatibility related activities, which majorly includes drafting and reviewing toxicological risk assessment reports, biological evaluation plans, biological evaluation reports against applicable standards, gap analysis of biological studies with current standards and contribution to business development under biocompatibility testing services.
