2 Amendments of Radvilė MORKŪNAITĖ-MIKULĖNIENĖ related to 2012/0266(COD)
Amendment 825 #
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, biological safety, sterilisation, software validation) shall have the following proven qualificationrequired specialist qualifications stipulated by the Member States. The required specialist qualifications include, for example:
Amendment 832 #
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 qualificationrequired specialist qualifications stipulated by the Member States. The required specialist qualifications include, for example: