https://mobirise.com/

BIOMEDICAL INNOVATION

BIOVIC was set up in April 2008 as a biomedical company specializing in the research, design, development, and manufacturing of state of the art biomedical devices - particularly those made from polytetrafluoroethylene (“PTFE”). 

MISSION

With the rapid growth of populations throughout the world, increasing disease rates (such as diabetes, kidney failure, cardiovascular disease etc.) and the escalating demands for advanced medical care and treatment have made the development and commercialization of medical device technology a global necessity. 


BIOVIC provides not only a product pipeline of innovative, high quality medical products, but also value-added benefits. Along with affordability, targeted market research and availability will contribute to an improved quality of life for those in the communities it serves. 


BioNexus is a special status awarded to qualified international and Malaysian biotechnology companies that undertake value-added biotechnology and/or life sciences activities.

QUALITY POLICY

"BIOVIC will design, develop and commercialize medical devices while meeting or exceeding customer, regulatory and other requirements and maintaining the suitability and effectiveness of our quality system."

BIOVIC QUALITY OBJECTIVES

  1. To operate our organization in a manner that emphasizes quality in every aspect of our business.
  2. To meet or exceed customer expectations along with all other product requirements.
  3. To primarily serve the medical device needs of the communities we serve.

MANAGEMENT TEAM

TARUN EDWIN
CEO & Chief Technology Officer

Tarun Edwin has more than 25 years of hands-on experience in the Biomedical industry. He is an accomplished Biomedical Engineer, and has patented, designed, developed, and commercialized numerous biomedical devices. He is an avid inventor, with 37 issued patents in his name and several more pending. PTFE, Vascular Grafts and Stent Grafts have been Tarun’s specialty. He has worked for several US companies in the roles of Manufacturing, R&D, New Technology Development and Intellectual Property. As Senior Program Manager at Bard Peripheral Vascular, his teams obtained clearances for more than five medical device 510k submissions and one extremely complex IDE-PMA. He was project manager and lead biomedical engineer for innovative products such as Venaflo™ and Distaflo™ PTFE grafts; and both invented and developed Bard’s Flair™ and Fluency™ stent grafts. In 2004 he was recognized for being the company’s most prolific inventor and was also awarded the coveted C.R. Bard “Scientific and Technology Achievement Award”. He holds several degrees which include the following:

•  BS in Electrical Engineering, Southern Illinois University
• BE in Biomedical Engineering, Arizona State University
• MS in Biomedical Engineering, University of Texas
• Global Bio-Entrepreneurship Course, University of California San Francisco

SUCHIT JACOB
Director of Business Development

Suchit Jacob has more than 15 years’ experience in sales and marketing management. He leads BIOVIC’s marketing efforts and is the acting CFO. With over 8 years of direct experience in biomedical operations, distribution management, pricing reimbursement guidelines, and market intelligence, he is now in the process of developing BIOVIC’s Marketing and Sales network. Suchit graduated with a BS in Business Administration, from Bemidji State University, Minnesota.

SCOTT PLETZER
Management Representative

Scott Pletzer has more than 25 years of quality and engineering experience from reputable medical device companies including Becton Dickinson, C.R. Bard, Boston Scientific and West Pharmaceuticals. Scott is a certified ISO 9001:2000 lead Auditor with vast knowledge and familiarity in Quality System Regulations (QSR), ISO 9001/13485 and European Medical Device Directive (MDD) requirements. Scott provides BIOVIC with QMS expertise related to the development, scale-up, commercialization, and maintenance; leading to improved time to market and regulatory compliance. Scott graduated with a MSc. in Bioengineering from Clemson University and has a BSc. in Mechanical Engineering from West Virginia University.

LORRI CHAVEZ
Regulatory Consultant

Lorri Chavez has over 20 years of Regulatory experience and coordinates all of BIOVIC’s Regulatory activity. Her positions in the past include:

•  Senior Regulatory Affairs Manager, Alliance Medical Corporation
• Senior Regulatory Affairs Specialist at IMPRA Inc.
• Project Manager at Ethicon Endo-Surgery, Inc (a division of J&J)
• Board Director, National Animal Supplement Council, NASC

Lorri graduated with a BSc in Liberal Arts from Xavier University, and has an MBA from the University of Phoenix specializing in Healthcare Management.

RUDY MOUNIA
Marketing Consultant

Rudy Mounia has over 30 years’ direct experience in the marketing and sales of vascular products, including PTFE grafts. He has worked for several large medical corporations including IMPRA and C.R. Bard, and has also worked for smaller companies such as Vasca and Vascular Flow Technologies developing marketing strategies and hiring their sales force. He has been providing valuable oversight and direction to BIOVIC’s global marketing strategy and will be personally coordinating the US sales and marketing effort. Rudy has a BA in Marketing Management from Alameda University.