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PRESS RELEASES
Contacts: Marc R. Viscogliosi, President
(212) 583-0250 ext. 103 mviscogliosi@mcrallc.com
MCRA
UNVEILS NEW BUSINESS UNIT FOR QUALITY ASSURANCE AND
INTERNATIONAL REGULATORY AFFAIRS
Former Patent Examiner joins orthopedics Intellectual Property team.
NEW YORK NY, February 9, 2007 - Musculoskeletal Clinical Regulatory
Advisers, LLC (MCRA) is pleased to announce the addition of a fifth
orthopedic business unit to its already established four core services.
Quality Assurance and International Regulatory Affairs has been incorporated
into the US regulatory, clinical, intellectual property and reimbursement
services that MCRA currently provides.
The division is spearheaded by Kevin Ladd, who has been involved in
the medical device industry for more than 20 years. Of those years,
15 were spent with TUV America, where he performed auditing and assessment
services in accordance to ISO 9001, EN 46001, ISO 13485, Medical Device
Directive (MDD) and Canadian Medical Device Regulation (CMDR). Mr. Ladd’s
experience ranges from working with start-ups to well-established orthopedic
companies, and in the past six years he has created complete quality
systems for multiple orthopedic device companies.
Supplementing the team are Stephen Page and Yves DeBacker. Mr. Page
also brings more than 20 years of experience in regulatory affairs and
quality systems expertise within the medical device industry. Mr. DeBacker
has been working in regulatory, quality assurance and reimbursement
for worldwide companies for more than 15 years. His main focus is on
orthopedic implants, spinal devices, orthobiologic products and biomaterials.
MCRA can assist any company in creating or modifying a quality system
to meet the requirements of the FDA QSR, ISO 13485, European Medical
Device Directive and Canadian Medical Device Regulation. These services
include creating a quality manual, standard operating procedures, work
instructions and forms, as well as training the organization’s
personnel in the regulations and standards. A proper quality system
is often overlooked by small companies and deemed cumbersome, but is
critical for regulatory compliance. Larger companies, on the other hand,
could benefit from MCRA’s services to streamline procedures and
improve efficiencies.
When a company is ready to introduce its technologies to the European
market, MCRA can create or update technical files and/or design dossiers
to meet the requirements of the MDD. Meeting these requirements by having
the proper documentation helps minimize the time to market.
Mr. Ladd said, “Foregoing a complete quality system will be a
large detriment to the livelihood of any company trying to sell its
products. It is imperative that companies understand the various nuances
of US quality system requirements versus those of Europe and other countries.
Quality assurance is just one of the paths that every company must tread
on its road to commercialization – I am excited to work with a
team that has the capabilities to guide a company along all roads leading
to approval by regulatory bodies.”
Marc R. Viscogliosi, President of MCRA, said “We are eager to
introduce this new service to our clients, which gives MCRA even more
integration and customization of services that it can provide for a
company. Kevin has built, maintained and audited quality systems for
a multitude of companies, making him well-suited to guide our clients.
When patient safety is paramount, taking responsibility for internal
and external quality is essential.”
David Lown, General Manager of MCRA, added “MCRA has a focused
discipline to offer integrated services in the key orthopedic value
creating initiatives for companies and their technologies. We are extremely
excited in Kevin joining the team, having found a prominent leader in
the review of and implementation of quality systems and international
regulatory endeavors.”
About MCRA, LLC
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a highly
specialized, independently operated consulting firm serving the worldwide
orthopedic industry. MCRA is a group of leading strategists committed
to executing regulatory, clinical, intellectual property, and reimbursement
strategies to move your company to successful value creation. Founded
in 2003 by Viscogliosi Brothers, LLC, the firm provides "first-in-class"
service to its clients through its superior knowledge base, global surgeon
relationships and deeply experienced management team. MCRA places particular
emphasis on working with companies at all stages of development, whether
they are single-product companies or companies with multiple technologies.
The true value of MCRA is the ability to cover the entire lifecycle
of a product or technology by taking a product from the conceptual pre-clinical
stage to market approval.
For more information visit www.mcrallc.com
About Viscogliosi Brothers, LLC
Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony
G. Viscogliosi in New York City in 1999, VB was the first venture capital/private
equity and merchant banking firm dedicated to the musculoskeletal/orthopedics
sector of the health care industry. Today, VB is a leading independent
firm with a mission to create, build and finance companies founded on
innovations developed by surgeons and uniquely focused on "life-changing"
musculoskeletal/orthopedic technologies. VB has worldwide surgeon, industry
and trade relationships and significant financial expertise in the musculoskeletal/-orthopedic
sector.
As principals of VB, the Viscogliosi brothers have a combined total
of more than 35 years experience analyzing and investing in the musculoskeletal/orthopedics
sector. They have pioneered innovative financial, strategic and management
initiatives for companies in the sector, from start-up, seed and development
stage all the way to exit, while helping thousands of people lead better
lives through the orthopedic and spinal products marketed and sold by
the companies they have assisted in developing and financing.
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