Medical Design Briefs - April 2021 - 21

...........................................................
Improve Public Health by Utilizing
Existing Expertise in the Aerospace
Industry
Steven Niedelman, Lead Quality Systems
& Compliance Consultant to the FDA and
Life Sciences Practice, King & Spalding
Uncover opportunities to improve
public health by utilizing expertise in the
aerospace industry, which is surprisingly
aligned with the medical devices industry.
Breakout Discussion: MedAccred®
Criteria for Electronics - Powered
by Interpower
Ralph Bright, VP, Marketing, Interpower
Group of Companies; Julia Markardt, Master
Instructor and Staff Engineer, MedAccred;
Michael Lau, Senior Designer, Stryker
An interactive breakout discussion
allowing attendees to ask questions to
better understand what MedAccred
looks for in the electronics area.

GOLD SPONSORS
BOSTON MICRO FABRICATION
Boston Micro Fabrication (BMF)
manufactures high-precision micro
3D printers for diverse use cases that
require the unique combination of
excellence in three key areas: resolution, accuracy, and precision. Using
polymer and composite additive
manufacturing, BMF is able to produce high-precision/high-tolerance
industrial parts.
BOYD CORPORATION
Boyd Corporation creates advanced
solutions that cool, seal, and protect
disruptive technologies. Integrated
solutions enable its customers to
innovate and redefine their industries and push their products further.
FUTEK ADVANCED SENSOR
TECHNOLOGY
FUTEK Advanced Sensor Technology specializes in creating innovative custom force and torque sensor solutions for today's leading tech
innovators. FUTEK's force sensors
are used in applications from subsea
to Mars. Its load cells, torque sensors, and multi-axis sensors are made
with one of the most advanced technologies in the sensor industry:
metal foil strain gauge technology.

DISTINGUISHED SPEAKERS
Kim Trautman, Executive Vice President
Medical Device International Services, NSF
Medical Devices
Kimberly A. Trautman, MS, is a medical devices
and In vitro diagnostics expert with over 30 years
of experience. She worked at the US FDA for over
24 years and with other regulatory agencies
around the globe, giving her both industry and
regulatory agency experience. She has a demonstrated history of working collaboratively with industry,
regulators and patient groups for the betterment of public
health. Trautman executes several medical device, IVD, and combination
product regulatory consulting services and has developed a formal education/
training business.
She is an Established an Authorized Medical Device Single Audit Program
(MDSAP) Auditing Organization and a new Notified Body for EU IVDR/
MDR Designation. She is an expert in global medical device regulations, has
written and harmonized the current 1996 US FDA Quality System Regulation,
and was on the international authoring group of ISO 13485 since inception
in 1994.
Trautman is an expert in combination products and was on the FDA authoring committee for 21 CFR Part 4. She conceived and developed the Medical
Device Single Audit Program and its consortium of five Global Regulators.
She is a 20-year veteran of the Global Harmonization Tasks Force (GHTF)
and foundational member of the International Medical Device Regulators
Forum (IMDRF). She is also a recognized international medical device expert
with a master's degree in biomedical engineering.

.......................
Steven Niedelman, Lead, Quality Systems &
Compliance Consultant to the FDA and Life
Sciences Practice, King & Spalding
Steve Niedelman serves as lead quality systems
and compliance consultant to the FDA & Life
Sciences practice team at King & Spalding, specializing in regulatory, enforcement, and policy
matters. He provides strategic advice, insight, and
guidance to the medical device, pharmaceutical,
biologics, and food industries to ensure FDA compliance. Niedelman retired from FDA in 2006 after a 34-year
distinguished career, serving as the deputy associate commissioner for regulatory affairs and as chief operating officer of the Office of Regulatory Affairs.
He ensured consistent interpretation of FDA's regulatory policies by directly
overseeing offices at the headquarters of ORA, including the Office of
Regional Operations, Office of Enforcement, and Office of Criminal
Investigations. Additionally, Niedelman assisted in the day-to-day management of the FDA's nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, he served as the principle liaison to CDRH
and was a member of the GHTF Steering Committee, FDA/Medical Device
Industry Grassroots Initiative Steering Committee, and the CDRH Post
Market Initiative Steering Committee. He also served on the steering committee to the pharmaceutical cGMP for the 21st Century Initiative as well the
Counterfeit Drug Task Force.

Medical Design Briefs, April 2021

www.medicaldesignbriefs.com

Cov

ToC

http://www.medicaldesignbriefs.com

Medical Design Briefs - April 2021

Table of Contents for the Digital Edition of Medical Design Briefs - April 2021