CE certification

Project Scope The scope of work is divided up into two parts: 1) The implementation of an ISO 13485 QMS for all facilities and processes within the certification scope and 2) CE marking requirements according to MDD 92/43/EEC: 1) ISO 13485 QMS 1.1 QMS Scoping 1.2 Compile QMS Manual including: ● QMS Company Profile Framework. ● Management Processes Framework. ● Core Processes Framework. ● Support Processes Framework. 1.3 Workshop sessions to create system content and implement the QMS. Assistance with compilation of Forms, Work Instructions, Procedures. 1.4 Internal Audit on company processes and operations to establish level of compliance. Including reporting and a list of findings / action items. 1.5 ISO 9001:2015 training 1.6 Facilitation of the Management Review Meeting and assistance with generating a record thereof. 1.7 Assistance with Forms, Work Instructions, Processes editing 2) Technical File according to MDD 93/42/EEC – 2007/47/EEC): No. Description Day(s) 2.1 Technical File Template with all applicable tables and categories 2.2 Risk Management ● Assist with Risk Management Documentation according to ISO 14971 ● Risk Management File ● Risk Plan risk activities for each Product Life Cycle ● Risk Analysis for identifying each Risk, determine the Index, the mitigation action as well as the residual risk controls ● Risk Report To report on every activity 2.3 Clinical Investigation and Evaluation ● Assist with Clinical Investigation and Evaluation Literature Search Route according to MEDDEV2.7.1 ● Clinical Investigation and Evaluation template ● Investigation and Equivalence Table template and focus areas 2.4 Usability ● Assist with Usability Study according to EN62366 ● Usability Study Design assistance 2.5 Essential Requirements (ER) ● ER Template ● Assistance with completing the ER Table and reference all harmonised standards 2.6 Assistance with Instructions for Use, Label and Packaging according to the MDD and harmonised standards 2.7 Biocompatibility ● Assist with the Biocompatibility Report according to ISO109931 2.8 Compliance Testing ● Assistance with Compliance testing to all harmonized standards at an accredited ISO 17025 Lab.