Peru Workshop on Medical Device Regulation: Policy and Technical Aspects

ASTM International PeruI recently presented three sessions as a leading keynote speaker for Medical Device Standards: Technical Training on Cardiovascular Materials and Device Aspects at the PERU Workshop on Medical Device Regulation: Policy and Technical Aspects, November 2-4, 2015.

The event was hosted by ASTM International Standards Alliance with USAID/ANSI. The primary audience was government regulators, national medical device technical committee, medical device users, purchasers from hospitals, companies and testing laboratories.  It was a great learning experience and in hope the start of greater fairness and effectiveness of healthcare for everyone.

I spoke on three areas related to medical device engineering:

1) Technical Training – Cardiovascular,F2514 – 08(2014): Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading.
2) Technical Training – Cardiovascular, Test Methods Stents, ASTM F2477-07(2013): Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents, plus Shelf-life Test Attributes for Endovascular Devices ASTM F2914-12.
3) Technical Training – Cardiovascular and Current Issues in Materials, Fatigue and Fracture and Testing of Implantable Devices; and Standard Guide for Testing Absorbable Stents, ASTM F3036-13.

I joined other ASTM colleagues, Kenneth R. St. John, PhD, who shared his perspective and experience with selecting biological test methods and biocompatability and Jon Cammack, PhD, who gave an overview of TC194 and ISO 10993.  You can find more information, including all of our presentations here: or request a copy.