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Blood cellsToday’s healthcare system is more advanced than ever before, and the human blood and plasma industry plays a significant role.  From collecting plasma and blood to researching and analyzing it, there is a great deal of work to be done for both scientific and practical purposes.  We work with both Plasma Collectors and Device Manufacturers, including IVD manufacturers. We work with plasma facilities across the country to provide comprehensive compliance and remediation services, which include facility auditing, compliance remediation, and site licensing assistance to help clients meet FDA quality system regulations.

PPTA Viral Marker Reporting is one of the aforementioned services, but what does it mean? Well, for starters, PPTA stands for Plasma Protein Therapeutics Association, which is an organization for the world’s leading source plasma collectors as well as producers of plasma-derived and recombinant biological therapeutics. Members of this association produce medicines for treating life-threatening diseases and serious medical conditions. Applications of these medicines can include burns, shock, bleeding disorders, and immune system deficiencies, among other afflictions.

Viral markers are extremely important in this industry, as they are essentially a way to keep track of the presence of a specific virus in an organism. When working with blood or plasma, especially during transactions to and from living, breathing organisms, letting a virus slip through the cracks can be a deadly mistake. Each month, the PPTA requires viral marker data reports to be submitted by all IQPP (International Quality Plasma Program) certified facilities. That’s why MEDIcept sets up reporting systems and assists in the reporting process for companies in the human blood and plasma industry – we know that you’ve got your hands full and we can lighten your workload. Call us today for more information at 508-231-8842 or contact us on the web!

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The Latest News

FDA Updates Special 510(k) Guidance

FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process. In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements....

Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting

The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental amalgam. Recent post-market issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological...

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...