REGULATIONS DIFFER FROM COUNTRY TO COUNTRY , BUT THE MAIN REQUIREMENTS FOR APPROVAL ARE ALWAYS THE SAFETY AND EFFECTIVENESS OF THE DEVICES .
I N D U S T R Y I N V E S T I G A T I O N components according to their density using thixotropic separating gels in closed systems .
Platelet-rich plasma ( PRP )
Platelet-rich plasma ( PRP ) therapy has gained popularity since the first reports of its clinical use in the 1980s and 1990s . More recently , the idea of using cells or growth factors to stimulate tissue regeneration at the site of injury has emerged . The relatively low cost and ease of use have facilitated the rapid expansion of PRP into medical practice .
The preparation of PRP has been greatly simplified in recent years with the development of commercial PRP preparation devices . These devices also allow for the preparation of PRP in compliance with health regulations and good practice requirements . PRP for therapeutic use should only be prepared with certified medical devices intended for PRP preparation .
To meet the need for standardised PRP preparations , Regen Lab has developed complex polymer-gel separation systems that efficiently recover platelets and plasma and remove red and white blood cells in an automated closed-loop system . This innovative technology combines the advantages , without the disadvantages , of the buffy coat and plasma PRP preparation methods .
These devices address the various challenges of effective PRP preparation following international medical device regulations , which means that the devices are effective for PRP isolation and safe for patients and operators . It also implies that the manufacturer must comply with all standards and requirements related to the production of medical devices . In addition , these devices must meet the needs of clinicians in various therapeutic areas .
REGULATIONS DIFFER FROM COUNTRY TO COUNTRY , BUT THE MAIN REQUIREMENTS FOR APPROVAL ARE ALWAYS THE SAFETY AND EFFECTIVENESS OF THE DEVICES .
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