NetZealous organized a two-day seminar on FDA device software regulation led by ex-FDA expert Casper Uldriks. The seminar addressed the challenges of regulating increasingly complex software given its faster pace of development compared to FDA's regulatory process. Uldriks discussed critical issues like software interoperability and remote hacking that the FDA must consider in its oversight. The seminar provided medical software professionals insights into FDA thinking and limitations to help with compliance.

1. NetZealous announces successful completion of
seminar on the topic, “FDA Device Software
Regulation” by Casper Uldriks
Fremont, CA, Apr. 22: Casper Uldriks, ex-FDA Expert and former Associate Center
Director of CDRH, Olsson was the Director of a two-day, in-person seminar that
NetZealous, a leading provider of regulatory compliance trainings for a wide range of
regulated industries, organized in Boston, MA on April 21 and 22, 2016. This seminar
was on the topic, “FDA Device Software Regulation”.
The exponential growth of software and its level of complexity and use have brought
both advantages as well as challenges. While the advantage is the advancement and
multiplicity of use in medical devices; the challenge relates to the regulatory aspect. The
medical software industry has been exploding at such a pace that it has far
outperformed and overtaken the speed at which FDA's regulatory process happens. No
matter how fast the FDA seems to be moving to regulate the use of software in medical
devices; it seems impossible for it to catch up with the pace of technology.
More details about the seminar can be had from
http://www.globalcompliancepanel.com/control/globalseminars/~product_id=90037
3SEMINAR?FDA-device-software-regulation-Boston

2. One cannot fully blame the FDA for this. Regulatory action appears to be slow relative to
innovations because the FDA’s validation is limited to the immediate use of the
software, while its problems could be related to other areas such as its environment of
use, or its performance with other software programs and software hacking, all of which
the FDA has to take note of.
Also, device software is often used in conjunction with other software-based devices,
whose interoperability with each other was never anticipated. This places a number of
challenges for the FDA: Can one software program defeat the performance capability or
backup safety features of another software program? When interoperability surfaces,
which software manufacturer takes the lead to solve the problem and deal with
proprietary software issues?
The FDA has to also deal with other complex questions: How does one anticipate and
defend against the malicious remote hacking and shutdown of an insulin infusion pump,
for instance? The FDA has to thus subject a device to the highest possible scrutiny.
While the FDA is justified in following this strict protocol; an unpleasant spinoff of its
stringent approach has manifested itself in another area: the fear of the risk of software
failure on the part of manufacturers. This apprehension has been so great that this
failure, which could outweigh all the benefits the device brings, has deterred clinicians
from releasing a device at all.
A handy guidance for medical software professionals is the current provisions that NIST
has put forth in recent reports, which FDA will integrate into its regulatory oversight.
This means that firms that design and market software should be aware of both the
letter and spirit of FDA regulations. These are the kinds of issues that were taken up
during this seminar.
The Director discussed critical question relating to this area. He took up for discussion
issues that require careful consideration and to which no obvious, black and white
answers seem to be available.
About the Director:

3. Casper Uldriks is an ex-FDA Expert and former Associate Center Director of CDRH,
Olsson. He served as a senior manager in the Office of Compliance and an Associate
Center Director for the Center for Devices and Radiological Health. He developed
enforcement actions and participated in the implementation of new statutory
requirements for FDA.
About NetZealous:
NetZealous, a Fremont, CA-registered organization, dba GlobalCompliancePanel offers a
broad range of high quality regulatory and compliance-related professional trainings
and services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory
compliance, biologicals, drugs, food and biotechnology.
Satisha Naraharimurthy, CEO of NetZealous said that the usefulness of this seminar lay
in the choice of the topic the Director took up for discussion. Coming at a time when
there is a big mismatch between the speed of innovation and the ability of the FDA and
other regulatory bodies to catch up with it; this seminar served a very important
purpose, he feels.
According to Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at
NetZealous, this seminar is an eye-opener for those in the medical devices software
industry, because they need to be compliant with all regulations passed by the FDA. An
understanding of the way this regulatory body works is a very important understanding
to be had, something that this seminar imparted very effectively, he believes.
Liju Mathew,Co-Founder and Chief Business Development Officer at NetZealous thinks
that attending a very perceptive learning session such as this seminar will go a long way
in helping software device professionals understand FDA’s thinking and limitations in
their regulatory work. Netzealous Bangalore Reviews show how much our services are
being praised in India.
Contact information:
Call: 1-800-447-9407;
Visit: http://www.netzealous.com/