NEW YORK, Dec. 5 /PRNewswire/ -- Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) today announced that Angela Byland has joined the firm as Director, Biologics Regulatory Affairs. MCRA is an independently-operated consulting firm focused exclusively on serving the worldwide orthopedics industry.
Ms. Byland has specialized in managing regulatory affairs and quality systems for medical devices for more than 12 years. Ms. Byland has supported regulatory activities for technologies such as, in vitro diagnostics, cardiology and spinal system devices. Prior to joining MCRA, Ms. Byland was Regulatory Manager for 'Peripheral Interventions' product lines at Boston Scientific Corporation, a developer and manufacturer of less-invasive medical devices.
Ms. Byland has authored multiple submissions to the U.S. Food and Drug Administration (FDA) in support of Class II and Class III medical devices, including Investigational Device Exemptions (IDE) and Premarket Applications (PMA). In orthopedics, Ms. Byland obtained premarket notification clearance and IDE for a spinal system device used for both fusion and non-fusion indications.
"I am thrilled to be joining a team of accomplished experts in orthopedic and spinal device technologies. I look forward to partnering with many of the industry's biggest names both in the U.S. and worldwide to help bring their new and innovative products to the market," said Ms. Byland.
Ms. Byland has a Bachelor of Science degree in Medical Technology from Winona State University. She completed her internship at United Hospital in St. Paul, MN and from there focused on toxicology testing and protein purification. She then entered the medical device industry where she held positions in manufacturing, quality systems and regulatory affairs. She is U.S. Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professional Society.
Marc R. Viscogliosi, President of MCRA, said, "Angela's experience in the medical device industry will complement MCRA's current regulatory team which has thorough knowledge of the U.S. regulatory process through their distinguished service at the FDA along with their collective experience in the orthopedic device industry."
David W. Lown, General Manager of MCRA, added: "With global growth in orthopedic devices continuing at record levels, demand is mounting for 'one-stop' consulting services on a global scale and this demands the kind of up-to-the-minute knowledge and expertise reflected in Angela's appointment."
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 (IP), 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 life cycle of a product or technology from the conceptual pre-clinical stage to market approval.
For more information, please visit MCRA's website: 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.
Contacts: Marc R. Viscogliosi, President William G. Armstrong, Jr. Viscogliosi Brothers, LLC The Dilenschneider Group (212) 583-0250 ext. 103 (212) 922-0900 mviscogliosi@mcrallc.comwarmstrong@dgi-nyc.com
Viscogliosi Brothers, LLCCONTACT: Marc R. Viscogliosi, President of Viscogliosi Brothers, LLC,+1-212-583-0250 ext. 103, mviscogliosi@mcrallc.com; or William G.Armstrong, Jr. of The Dilenschneider Group, +1-212-922-0900,warmstrong@dgi-nyc.com
Web site: http://www.mcrallc.com/
