Sohan K.

Sohan K.

PuneIndia

ISO 13485 I Medical Device Regulatory I Vendor Development

Core skills: Manufacturing, Regulatory, Quality, Vendor Development, Supply Chain Management Medical Device/ IVD Regulatory Affairs ISO 13485 Certification  Preparing Quality Manual, Procedures, Process Flow  Design & Development QMS documentation  Design Risk Assessment per ISO 14971, DFMEA  QMS Risk Assessment  Medical Device File  Internal Audit  MRM  Finding Right Auditing Agency  Coordinate Final Audit  Provide Training on ISO 13485 & ISO 14971 Clinical Trial/ Clinical Investigation/ Clinical Performance Evaluation  Need Assessment  Clinical Trial Protocol Design Vendor and Component/Device Development (Medical Device/IVD MD/ General Engineering products (Metals, plastic, silicon, rubber, etc.)  Establish Supply Chain for any product  Identify right suppliers in shortest time  Prepare Supplier Evaluation Checklist  Conduct Supplier Evaluation  Process Design  Process Risk Assessment (PFMEA)  Process Validation Protocol Writing  Carry out Process Validation  Problem Solving through Root Cause Analysis (RCA) Currently heading the India Operations @ Subhag Healthtech, a MedTech Start up since Sept 2020. Previously Worked with GE India (6 years), American Axle (2.5 yrs), Mahindra & Mahindra (7 yrs).
Sohan K.

Sohan K.

PuneIndia

ISO 13485 I Medical Device Regulatory I Vendor Development

Specializes in
Core skills: Manufacturing, Regulatory, Quality, Vendor Development, Supply Chain Management Medical Device/ IVD Regulatory Affairs ISO 13485 Certification  Preparing Quality Manual, Procedures, Process Flow  Design & Development QMS documentation  Design Risk Assessment per ISO 14971, DFMEA  QMS Risk Assessment  Medical Device File  Internal Audit  MRM  Finding Right Auditing Agency  Coordinate Final Audit  Provide Training on ISO 13485 & ISO 14971 Clinical Trial/ Clinical Investigation/ Clinical Performance Evaluation  Need Assessment  Clinical Trial Protocol Design Vendor and Component/Device Development (Medical Device/IVD MD/ General Engineering products (Metals, plastic, silicon, rubber, etc.)  Establish Supply Chain for any product  Identify right suppliers in shortest time  Prepare Supplier Evaluation Checklist  Conduct Supplier Evaluation  Process Design  Process Risk Assessment (PFMEA)  Process Validation Protocol Writing  Carry out Process Validation  Problem Solving through Root Cause Analysis (RCA) Currently heading the India Operations @ Subhag Healthtech, a MedTech Start up since Sept 2020. Previously Worked with GE India (6 years), American Axle (2.5 yrs), Mahindra & Mahindra (7 yrs).
More than 30 hrs/week