Ken Block Consulting
Stand number: K7
Ken Block Consulting assists companies throughout Europe to successfully bring products to market, plus solve challenging regulatory and quality system issues. We help clients comply to regulations and standards including the Medical Device Regulation, Medical Device Single Audit Program (MDSAP), FDA Quality System Regulation, ISO 13485:2016, ISO 14971, IEC 62304, Guidance Documents, etc. Our team provides on-site client services including gap analysis & mock audits, FDA inspection management, training, IQ/OQ/PQ, Validations, etc.
Associations and Memberships: RAPS, ASQ, AAMI
Consultants
Address

75 Boulevard Haussmann

Paris

75008

France

+33 (0)1 42 68 51 79

Website

 


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