Quality Management System Compliance:

We make sure through administrative and procedural activities implemented in a quality system that your medical device meets the specifications and requirements.

• Establishment and implementation of Quality Management Systems

• Issuing and maintaining of the Quality Manual and Quality Procedures

• Establish MRB, CAPA, Training, Labeling, Document Control and Internal Audit systems

• Clean Rooms, Sterilization, Packaging & Transportation validations

• Gap Analysis - assessment of your existing compliance with the current applicable requirements

Auditing:

Audits are executed to determine regulatory compliance and improve effectivity of your processes and those of your critical subcontractors and crucial suppliers

• Internal Audit - Essential to continuously improve your process and essential for full regulatory compliance.

• Subcontractor / Supplier Audit - Audits of critical subcontractors & crucial suppliers are vital to your Quality Management System

• CE Pre-Audit - With a CE Pre-Audit we guide you through the audit process before the Notified Body appears

• Unannounced Audit by Notified Body