PRP IS NOW A KEY PLAYER IN THE MEDICAL WORLD WITH MILLIONS OF PATIENTS TREATED EACH YEAR .
I N D U S T R Y I N V E S T I G A T I O N
The manufacturer must have a quality management system certified to ISO 13485 and a risk management system ( ISO 1471 ).
It must perform ongoing clinical evaluation ( ISO 14155 ) and post-market surveillance ( ISO / TR 20416 ) to verify the safety and performance , including clinical benefit , of the device when used as intended by the manufacturer . Manufacturing processes must be validated .
PRP preparation devices must be manufactured to be sterile ( ISO 11737 , 17665 , 11137 ); packaged to maintain sterility throughout the life of the devices ( ISO
PRP IS NOW A KEY PLAYER IN THE MEDICAL WORLD WITH MILLIONS OF PATIENTS TREATED EACH YEAR .
11607 ) and labelled appropriately ( ISO 15223 ). Second , to be marketed , a medical device must be approved by the health authorities in each country . Regulations differ from country to country , but the main requirements for approval are always the safety and effectiveness of the devices .
In the European Union , there is a single regulation – the MDR 2017 / 745 , which replaces the MDD 93 / 42 EEC – applicable for all members and for other countries outside the Union that have decided to follow this regulation .
Under this regulation , medical devices for the preparation of PRP are classified as IIa or IIb and must be certified by a notified body .
The process
To maintain the PRP in liquid form until it is used , a PRP device must contain a reversible anticoagulant . The use of a reversible anticoagulant having a neutral pH ( pH 7 ) and not containing any sugar , such as sodium citrate , which is more physiological and has no side effects on the patient is pre-dosed in the tubes .
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