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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!

News and Resources

Person Responsible for Regulatory Compliance

Person Responsible for Regulatory Compliance

As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC). This individual (or...

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MEDIcept

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200 Homer Ave
Ashland, MA 01721

508-231-8842