
About
Us
MDVentures
develops professional alliances to assist businesses to expand, grow
and succeed in the global marketplace. We provide technical expertise
and professional local representation to assist small and medium sized
medical device manufactures with timely introduction and support of
their products in the marketplace. The United States represents the
single largest market in the world for medical devices, representing
as much as 65% of total sales for some medical device market segments.The
U.S. market is highly regulated with many legal requirements for both
manufacturers and their products.. A practical and effective regulatory
capability is essential to successful entry into this market.
MD Ventures offers a complete set of retained and contract services
to help your company comply with regulatory requirements. Our staff
and associates are knowledgeable professionals with extensive hands-on
experience in the medical device industry. Through our European associates
we can provide our customers with entry into the European medical market
as well.
VISION
MDVentures
provides technical expertise to assist in the development and maintenance
of company systems, regulatory requirements, quality systems, product
design/improvement, sales and distribution in the United States and
in Europe.
Local USA and E.U. Representation
Clinical Trials
Facility Registration & Product Listing
Quality System Audits and GAP Analysis
MDE, Corrective Actions & Internal
Audits
FDA and MDD Compliance
Product Submissions
ISO 9000, EN46000 & CE registration
Product Performance Testing
Design and Sustaining Engineering
Product and Process Validations
Sales and Distribution
MISSION STATEMENT
MD Ventures is committed to providing professional local
representation with a full line of engineering, regulatory, clinical
and quality system services to assist medical device manufacturers with
timely introduction and support of their products in the USA and European
markets.
PERSONNEL
Tom Shanks: President and Founder
Gus Bock: Co-Founder; Regulatory, Clinical and Quality Systems
ASSOCIATES
John Karpowicz: Engineering and Operations
Robert Johnson, MD: Clinical Affairs
Michael Rinck, Ph.D.: European Regulatory and Clinical Affairs
Craig Lindholm: Marketing and Distribution
John LaMascus: Drugs, Biologics and Combination Products
Thomas P. Shanks
Thomas Shanks has 22 years experience in the medical
device industry with Hudson RCI, a worldwide market share leader in
disposable respiratory care and anesthesia products where he held management
positions in Product Development and Quality Assurance. Prior to joining
Hudson RCI, he was with Deutsch ECD, a privately held company producing
high performance, environmentally sealed interconnection devices used
in aircraft, space, and ground-based military vehicles. While there
he held positions in materials and process engineering and was Product
Engineer for the company's line of Electrical Magnetic Interference
(EMI) Connectors.
Mr.
Shanks is an executive committee member of ASTM Technical Committee
F29 and the associated US Technical Advisory Group (USTag) to ISO TC121
which deals with the performance and safety requirements for anesthetic
and respiratory equipment. He has extensive experience interfacing with
FDA and European regulatory authorities regarding technical matters.
Mr. Shanks holds a Bachelor of Science degree in Chemical Engineering
from California State Polytechnic University at Pomona, is a certified
quality auditor (CQA), ISO 9000 lead auditor and is experienced in all
aspects of quality systems.
Gustavus
D. Bock
Mr. Bock has held vice president and director positions
at Hudson RCI, Birtcher Medical Systems, InnoVision Medical, IOLAB (Johnson
& Johnson) as well as senior management and technical positions
at American Hospital Supply Corporation, CILCO, and Cardiovascular Devices,
Inc. He holds a Bachelor of Arts degree in Biology from California Western
University, a MBA degree from Claremont Graduate School, and an Aeronautical
Engineering Certification from the U.S. Air Force Academy.
ASSOCIATE
BIOS AND C.V.s AVAILABLE UPON REQUEST