Mohamed Shaik Ashik R

As a biocompatibility specialist with 2+ years of experience, I am looking for a challenging role that utilizes my 
skills and knowledge to ensure medical device safety and efficacy. My expertise in conducting biocompatibility testing, report writing, analyzing toxicological data, and providing regulatory support will make a valuable contribution to the organization’s success while ensuring compliance with global regulatory requirements. 

 Conducted biocompatibility standard gap assessments on medical devices to ensure compliance with global 
regulatory requirements and standards.
 Identified potential gaps and provided effective solutions, leading to enhanced product safety and regulatory 
compliance.
 Effectively contributed in writing biological evaluation reports (BER) in accordance with ISO 10993 for 
summarizing the biological safety of medical devices and successfully sent for regulatory submissions.
 Coordinated with test labs and device manufacturers to conduct biocompatibility and chemical characterization 
testing in accordance with the ISO and other applicable standards.
 Reviewed the study protocol and reports, aligning them with current guidelines, and shared final test reports, 
guaranteeing accurate and reliable results.
 Conducted toxicological risk assessment (ISO 10993-17) for leachables identified in extractables studies (ISO 
10993-18), calculating the margin of safety (MoS) to ensure safe exposure levels.
 Successfully gathered and prepared over 200 toxicological data sets for chemicals present in medical devices, 
demonstrating meticulous research and data analysis skills.
 Utilized various literature sources like ECHA and PubChem to compile comprehensive toxicological 
information.
 Contributed in creating a toxicological automation tool for the effective calculation of MoS (Margin of safety) 
and this automation tool includes toxicology data, regulatory limits (Reference dose (RfD), Derived no effect 
level (DNEL), Acceptable daily intake (ADI), Permissible daily exposure), Toxicokinetics, Pharmacology, and 
Physiochemical data’s of a chemical present in the medical device.
 Conducted CMR assessments on the raw materials present in the medical devices to confirm the presence of 
CMR 1A or 1B, Endocrine disruptors, etc., are below the threshold limit of 0.1% w/w as per the 2017/745 annex 
1, GSPR 10.4 and 10.6 guideline.
 Worked collaboratively with cross-functional teams to resolve biocompatibility issues and provide technical 
expertise to support product development.

B.E BIOMEDICAL ENGINEERING| 2017-2021 | SKR ENGINEERING COLLEGE
 Major: Biomedical Engineering
 Minor: Electronics Engineering
 CGPA: 7.57/10
 Related coursework: Biomedical instrumentation, Diagnostic and therapeutic equipment, Radiological 
equipment, Hospital management, Digital image processing, Medical Physics, Biochemistry, Human anatomy 
and physiology, Pathology and microbiology, and Embedded systems.
 Final year project title: A compact device for intravenous fluid delivery
 Project summary: Designed compact and magnetic resonance imaging compatible infusion pumps to accurately 
deliver the various intravenous fluid for every critical patient even in the magnetic resonance imaging room.