REGULATORY

Consultants

Janice Hogan

Janice HoganJanice Hogan has been involved in medical technology for over 25 years. From her engineering training at M.I.T. to work in the pharmaceutical industry, to her current practice representing medical device companies before the FDA, Janice has focused her career on the intersection of technology, regulation, and healthcare.

Read more about Hogan and Lovell Law Firm >
Philadelphia, PA
FDA consultant attorney

Shayne Gad

Shayne GadDr. Gad has more than 38 years of broad-based experience in toxicology, drug and device development, statistics, and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, inhalation toxicology, immunotoxicology, and genotoxicology. A past president of the American College of Toxicology and the Roundtable of Toxicology Consultants and the recipient of the 2008 ACT Lifetime Achievement Award, Dr. Gad has authored or edited 47 books, 58 independent chapters and more than 350 papers and abstracts in the above fields.

Read more about Gad Consulting >
Raleigh, NC
Expert Toxicologist

Andrea Siller

Andrea SillerShe is recognized for her research skills coupled with her administrative capacity. She worked as a research assistant at Rice University in Houston, Texas, where she collaborated on studies of cancer treatment techniques and improvement the quality imagenologial with nanotechnology. Her active participation in the Tec de Monterrey, where she graduated with Excellence of Biomedical Engineering, allowed her to collaborate in the design of a microfluidic device for detecting circulating tumor cells. She also worked as a consultant in the area of ​​innovation for a multinational company and conducted research models to encourage the development of technology-based startups.

Read more about Bioana >
Mexico
Engineer, FDA Consultant

 

Andrea Siller founder of Bioana Sa De Cv, one of Ziptek's FDA Consultants, meeting with the President of Mexico, Enrique Pena Nieto, speaking on behalf of Mexico's global entrepreneurial efforts to globalize and introducing Ziptek LlC and Ziptek Mexico Sa De Cv with the products-knotless tissue repair and attachment solution devices.
Andrea Siller founder of Bioana Sa De Cv, one of Ziptek’s FDA Consultants, meeting with the President of Mexico, Enrique Pena Nieto, speaking on behalf of Mexico’s global entrepreneurial efforts to globalize and introducing Ziptek LlC and Ziptek Mexico Sa De Cv with the products-knotless tissue repair and attachment solution devices.

Mexico Stepping Out! The Next China?

[pc-login-form]

[pc-logout-box]

[pc-pvt-content allow=”38″ warning=”1″ message=”You are not verified to view this content. Please Log In.”]

Ziptek Regulatory Documents

Materials

  • COA/Trace/Cert
    • Handle-Polysulfone
    • Wire- Nitinol
    • O-Ring- Silicone
    • Capture- Resorbable PLA Copolymer
    • Plug- PLDLA
    • Suture- UHMWPE
    • Tip Covers- TPE
    • Driver- Stainless Steel
    • Screws-Titanium
    • Bumpers- UFP

Literature Standards

  • Biomechanical Rationale
  • Contact Surface Area
  • Cyclic Loading
  • Gap Formation
  • Knot Strength
  • Pull-Out
  • Pull-Out Angular Differences
  • Pull-Out- Osteopenic
  • Rip-Through
  • Row Strength

[/pc-pvt-content]