Clearwax Ltd

part 3 (a) of Article 15 of the Medical Device Regulation EU 2017/745 and therefore assures the PRRC that conformity of devices will be appropriately checked before release, and so is assigned to an appropriate person within the Company’s organization

assuring on a continuing basis that; a) Procedures exist to assure the conformity of any PRODUCTS manufactured under the labeled name of the MANUFACTURER has been appropriately assessed b) The technical documentation & declarations of conformity are drawn up & kept up to date c) Post Market Surveillance obligations are compiled as per Article 83, 84,85 and 86 of MDR 2017/745 d) The reporting obligations in regard to vigilance and adverse reporting as per Articles 87 to 91 of MDR 2017/745 are met