Angela Sanchez

Angela Sanchez has been in the MedTech industry for 22 years, with 12 of those years focused on medical devices in all major therapeutic areas. She has done extensive work in permanent implants including orthopedic, cardiovascular devices, intravascular catheters, and absorbable medical devices including wound dressing and tissue-engineered devices.

Angela has a Bachelor’s degree in Chemistry. She started her career in the pharmaceutical research space working on synthesizing the therapeutic reagent siRNA (small interfering RNA). This work was focused on synthetic and analytical chemistry method development.

Angela holds voting membership with The Association for the Advancement of Medical Instrumentation® (AAMI) for multiple working groups including BE-WG11 – Allowable limits for leachable substances and BE-WG14 – Material characterization. She has interacted on behalf of clients through meetings or written responses to regulatory agencies such as the United States FDA, European Union Notified Bodies, Japan PMDA, and China FDA in regards to chemical characterization inquires of medical devices.

CORE COMPETENCIES

• Working knowledge of FDA, EU MDR and other global medical device regulations, as well as chemical characterization regulations within the ISO 10993 series
• Preparing gap analysis documents to ensure previously performed material and chemical characterization studies comply with most the recent regulatory requirements and provides chemical significance of differences that may be observed
• Interacting with clients on technical issues related to material characterization
• Ensuring compliance with industry regulations by implementing comprehensive policies and training programs for staff members
• Defending ISO 17025 and ISO 10993:18 instrument analysis, calculations, and interpretation for pre-market approval to regulatory bodies
• Developing new testing methodologies meeting regulatory and standard requirements
• Interpretating of non-volatile compounds by Ultra Performance Liquid Chromatography Ultra-Violet Mass Spectrometry (UPLC-UV-MS) and Gas Chromatography Mass Spectrometry (GC-MS)
• Working knowledge on all other lab techniques including:
  • Inductively Coupled Plasma Mass Spectroscopy (ICP-MS)
  • Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
  • Fourier Transform Infrared Spectroscopy (FTIR)
  • Ion Chromatography (IC)
  • Gel Permeation Chromatography (GPC)

RECENT PROJECTS

• Lead chemical characterization support for successful Investigational Device Exemption Application (IDE) of catheter device systems
• Lead glutaraldehyde validation expert for successful Premarket Approval (PMA) submission

PUBLICATIONS

• Delaney M.O., Thomas A., Rickets C., Kitchen D.E., and Kaiser R.J. (2008). Chromophoric 5’-O-Silyl Protection of N-Protected 2’-ACE Ribonucleosides for Solid-Phase RNA Synthesis. In:  Current Protocols in Nucleic Acid Chemistry. John Wiley & Sons, Inc, pp. 2.14.1-2.14.26.