E-Medix Ltd

The responsibilities identified in Article 15 are undertaken by Simon Checkley with the support of a qualified Regulatory Consultant, re: Clause 2 of Article 15. Responsibilities include:- The conformity of the devices is correct in accordance with the QMS prior to release. - The technical documentation and DoC are drawn up and kept up to date. - The PMS obligations are complied with. - The reporting obligations are fulfilled. Responsibilities identified in Clause 3 of Article 15 will be met.