Mechanics

Development of micro-optic resonance fiber scanner

• Design and Interpretation of actuator based on piezoelectric element

• Development of packaging micro-fiber

• Development of MEMS scanner etc.

Optics

Design of laser optic microscope system based on optic fiber

• Development and packaging of optic system in confocal fluorescence microscope

• Improving light-efficiency and light-noise based on optic fiber

• Improving image quality and resolution

Analog

Development of analog board

• Design AD-DA circuit and RF signal

• Design the system and Micom application

Software

Development of computer vision and image processing SW

• Development of algorithm about processing from signal to image

AI

Development of AI assistance diagnosis solution on medical images

• Developing of the solution for AI learning database management

• Development of algorithm for AI diagnosis and API, Implementation

• Submit the paper in AI journal and present in AI conference

Regulatory Affairs

• Domestic and international medical device / in vitro diagnostic device regulatory affairs(MFDS, CE MDR, CE IVDD, CE IVDR, FDA, etc.)

• Management and assisting regulatory affairs before commercialization (TCF, FMEA, SW validation, etc.)

• Prepare various document For applying the test(safety test, validation test, function test)

• Respond the judgement for GMP, ISO 13485, cGMP, and MDSAP, etc.tt

• Documentation of quality system, Building facilities, etc.

• Post management(Advertisement, device history, monitoring, manufacturing and repairing result, management of the devices, etc.)

Reimbursement and clinical trial

• Direct preparation and writing required documents for applying IND (Monitoring clinical trial, factual survey, unusual point report, etc.)

• Documentation for checking upon the existing health technology

• Establishment of the strategy for evaluation new health technology(Analysis of clinical paper)

• Documentation and applying for evaluation new health technology

Business plan

• Study on domestic / international medical device industry

• Domestic / International market research through utilizing public data

• Research for establishing business strategy

• Governmental project

Clinical Marketing

• Researcher

• Communication with key opinion leaders and hospitals

• Study on cancer application through clinical paper

• Make a plan for clinical trial

• Establishment of strategy for verifying utility validation to the medical device

• Assistant researcher

• Assist tissue imaging using fluorescence

• Make data for AI learning

• Join in domestic / international clinical conference

HR

• Establishment of recruiting plan and strategy by jobs

• Recruiting and Screening applicants

• Searching for the suitable staffs

• Explanation for recruiting and interview, offer, HR

• Search for information about HR

• Education, Organization management, Organizational culture