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.