Priya Darshini Arjunan

Current

• Quality and Regulatory Engineer at HD Medical Services India Pvt. Ltd

Education

• World Intellectual Property Organisation
• National Registration Board for Personnel and Training (NRBPT)
• University of Madras

1 more...

Recommended

2 people have recommended Priya Darshini

Connections

68 connections

Industry

Medical Devices

Websites

• My Blog
• My Blog

Priya Darshini Arjunan’s Summary

3+ years of experience in setting up (from scratch) a Quality system compliant to ISO 9001 requirements

Experience in Quality Management systems and Mandates for Medical Device Industry

Conversant with PDLC and SDLC

Priya Darshini Arjunan’s Experience

• Quality and Regulatory Engineer

  HD Medical Services India Pvt. Ltd

  (Privately Held; 11-50 employees; Medical Devices industry)

  May 2005 — Present (4 years 8 months)

  Primary focus:Design, development and manufacture of non invasive cardiac devices
  
  Being in the medical device domain, we are regulated by international directives such as the MDD and the FDA, and by mandatory Quality certification ISO 13485.
  
  I have successfully implemented and maintained an ISO 9001compliant quality system for the past 2 years.I am currently involved in defining and implementing an ISO 13485 compliant system.
  
  I also have exposure to the FDA QSR, and understand very well the inter-relationships between the ISO 13485, MDD and QSR mandates. I also read much on HIPAA.
  
  Standards that I have working knowledge of :
  ISO 14971 for Risk management,
  ISO 14155 for conducting clinical trials
  IEC 60601.
  
  I have formal training in SDLC and have used the techniques therein in requirements gathering, requirement analysis and testing.
  I pride myself in my writing and presentation skills
  
  Other interests:
  SPC
  The Six Sigma way
  Software QA
  IP Laws.

Additional Information

Priya Darshini Arjunan’s Websites:

• My Blog
• My Blog

Priya Darshini Arjunan’s Interests:

quantitative problem solving, etymology, language skills, logical reasoning, interpreting advertisements,personal financial management

Priya Darshini Arjunan’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch