Compliance

·         Establish, implement and develop quality systems compliant with ISO 9001:2000
ISO 13485:2003 and US FDA requirements

·         Management Representative according to ISO 9001:2000 and ISO 13485:2003

·         Document Control

·         Corrective, Preventive and Improvement actions Systems

·         Internal Quality Audits

·         Supplier Audits and evaluations

·         Customer Complaint handling Systems

·         Labeling requirements

·         Manufacturing process validation consulting

·         Design control requirements

·         Risk Assessments according to ISO 14971

·         Training in all of these areas

  

Regulatory

·         Product Classifications

·         Strategy development for the choice of conformity assessment and choice of Notified Body for
CE-marking

·         Preparation and management of product submissions on different markets including US and Canada

·         Vigilance reporting and recall management

·         Monitoring of MDD developments

·         Training in all of these areas

  

Other Services

·         Communication with Authorities and Notified Bodies

·         Product sterilization issues

·         Standards expertise

·         Authorized EU representative responsibilities

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