Name variants:
Indu Lakshman
Last updated May 13, 2024
Contact Information
Last Update
Jun 22, 2022
Email
in**@optovue.com, in**@scanadu.com, il**@yahoo.com
Location
San Francisco, CA
Company
Workplace
Senior Director of Regulatory Affairs and Quality Assurance
Fremont, CA
Industry
Medical Devices, Mfg Surgical/Medical Instruments, Nonclassifiable Establishments, Whol Medical/Hospital Equipment, Surgical and Medical Instrument Manufacturing
Colleagues
Work History
Senior Director of Regulatory Affairs and Quality Assurance
2800 Bayview Dr, Fremont, CA 94538
Executive of Regulatory Affairs and Quality Assurance. US and International regulatory affairs. MDSAP implementation, inspection and certification, ISO13485:2016 certification, EU MDR transi...
from Aug 2017
Vice President of Quality
California
Scanadu is a Silicon Valley medtech company developing a portfolio of medical devices for consumers. The company is seeking FDA clearance for all its products before bringing them to market ...
Nov 2014 — 2017
Senior Manager, Quality and Regulatory Affairs
1910 east Innovation Park Dr, Tucson, AZ 85755
Digital Pathology Scanners, Imaging and Enterprise Workflow Software. Site Head and Functional Leader. Successfully lead ISO 13485 & CMDCAS audits, FDB inspections and FDA inspections [no 48...
Jan 2012 — Nov 2014
Senior Director, Quality and Regulatory Affairs
919 Hermosa Ct, Sunnyvale, CA 94085
Head of Quality, Clinical Studies, Compliance and Regulatory Affairs Digital Pathology Capital Equipment, Imaging Software and Enterprise Workflow Software. Obtained FDA 510(k) clearances fo...
Oct 2007 — Jan 2012
Leader, Product Management
1 Towne Sq, Southfield, MI 48076
Web Based Software Applications for Supply Chain & Relationship Management (Enterprise Software). Headed the software products for supply chain (e-business workflow processes)
Nov 2005 — Oct 2007
Quality
100 Boston Scientific Way, Marlborough, MA 01752
Product Development and Design Quality Engineering, Operations and Manufacturing Quality, Quality Improvement, Supplier Quality, QA Inspections/Testing for Cardiac Surgery Products
Aug 2000 — Oct 2005
Quality Assurance Manager
Semi-conductor Capital Equipment Manufacturer. Head of Quality and Software QA
Nov 1997 — Mar 1999
Qa and Qe Manager
Implemented and Certified the company for ISO 13485 & ISO 9001. Quality System Management Rep. Manufacturing operations, manufacturing/process engineering, and quality engineering.
Apr 1992 — Oct 1997
Education
Occupations
Executive
Senior Director
IT Professional
Software Tester
Vice President
Doctor
Urologist
Senior Manager
Operations Manager
Computer Specialist
Chief Executive
Physician
Skills
Fda
Iso 13485
Medical Devices
Capa
Quality Control
Quality System
Design Control
21 Cfr Part 11
Quality Assurance
Iso 14971
Product Development
Regulatory Affairs
Supplier Quality
U.s. Food and Drug Administration
Biocompatibility
Pma
Software and Hardware Product Development
Iso 10993
Sterilization
Qa Inspections/Testing
510K
Department Budgeting