Bhaskar Chikkanna
Director of Quality Assurance and Regulatory Affairs @Perspectum Ltd
Signup · Get unlimited contacts
WORK HISTORY
Director of Quality Assurance and Regulatory Affairs @Perspectum Ltd
EDUCATION
University of Surrey
MSc, Biomedical Engineering
Dayananda Sagar College of Engineering
Engineer’s Degree, Medical Electronics
Christ University, Bangalore
Science
SKILLS
ABOUT BHASKAR CHIKKANNA
Quality without complexity’Strategise regulatory pathways and manage regulatory affairs for market authorisation and surveillance of medical devices. Have gained experience with eye biometry applications, cancer analysis, assay monitoring, machine vision applications, fluorescence based applications and artificial intelligence based software medical devices.Have developed from scratch and managed quality management system compliant to ISO 13485 and US FDA Title 21 CFR part 820, which addresses other consensus standards such as EN 62304, EN 82304, ISO 15223-1 and ISO 14971. Have designed and developed software applications for confocal signal processing & analysis, 2D/3D image/volume construction, image processing & analysis and DICOM image extraction & anonymisation. A rationale creative thinker and a finisher with strong problem solving skills, who enjoys new challenges and responsibilities. Possess strong leadership, organisation, management and customer relationship skills.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.