Hello! I'm Sherry

 

Medical device product development specialist; focusing on regulatory strategies and preparedness of technologies for market clearances in Asia, Europe, and the United States. Experienced in product design control elements and expedite the product development process.

SHERRY WANG

 
Email:

mddsnetwork@gmail.com

EXPERIENCE
 
2017 - Present

Lead Consultant

MDDSN Consulting Firm | Taipei, Taiwan

2011 - 2016

Department Manager

Industrial Technology Research Institute | 

Hsin Chu, Taiwan

2012- 2013

Project Manager

Supra Incubation and Integration Center |  Hsin Chu, Taiwan

2008 - 2011

Senior R&D Engineer

Medtronic Inc. | Memphis, TN

2001 - 2002

R&D Scientist

Boston Scientific | Wayne, NJ

EDUCATION
 
2005 - 2009

Biomedical Engineering, Ph.D.

Rutgers University | Newark, NJ

SKILLS
 

DESIGN CONTROL

QUALITY SYSTEM

510(K)

PMA

CE TCF

MDR

EXPERTISE
US FDA
  • Device Pre-submission package preparation and reviewer conferences

  • 510(k) submission package preparation and Additional Information (AI) responses

  • PMA product development, design control management and process

  • Quality Systems Regulation (QSR) preparedness for device manufacturing for exportation to the US

Europe
  • Medical Device Regulations (MDR) 2017 product development requirements

  • CE Technical Construction File preparation

  • MEDDEV 2.7.1 Rev. 4 Clinical Evaluation Report readiness

  •  ISO 13485:2016 transition requirements

TFDA
  • STED format submission

  • Regulatory requirements for product development

CFDA

  • General device submission requirements

 
CONTACT ME
 

SHERRY WANG

Email:

mddsnetwork@gmail.com

Success! Message received.