2 Amendments of Radvilė MORKŪNAITĖ-MIKULĖNIENĖ related to 2012/0267(COD)
Amendment 375 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.5 – introductory part
3.2.5. The personnel responsible for carrying out product related review (e.g. design dossier review, technical documentation review or type examination including aspects such as clinical evaluation, sterilisation, software validation) shall have the following proven qualificationan appropriate qualification certified by a competent authority of a Member State. Appropriate qualifications are, for example::
Amendment 377 #
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.6 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.6 – introductory part
3.2.6. The personnel responsible for carrying out audits of the manufacturer's quality management system shall have the following proven qualificationan appropriate qualification certified by a competent authority of a Member State. Appropriate qualifications are, for exampl::