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Welcome to Your Partner in Compliance Excellence 

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Naomi Allkins

"My mission is to empower companies to reach the "State of the Art" while ensuring compliance is upheld and patient safety is always protected"

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SERVICES

  • Internal Audit 

  • Investigation and Root Cause

  • Corrective and Preventative (CAPA) Management

  • Process Management

  • Data Integrity

  • Risk Management

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Quality Management 

  • Support guidance on QMS standard implementation

  • Full QMS Document review​​​

Consulting Services

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  • Meeting Regulatory Requirements

  • Technical File review

  • BS EN ISO 13485

  • BS EN ISO 14971

  • ISO 17025

  • EU/MDR​

  • Management System understanding of how to assess requirements

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  • Preparation for Notified Body Audits / Inspections​

  • Pre-audit inspection service (onsite / remote)

  • How to conduct a notified body audit

  • Decontamination of Re-usable Medical Devices

  • Single Use Devices requirements

  • Clear Guidance on streamlining processes

  • ​Best Practice Guidance​

Address

3rd Floor, 86-90 Paul Street, London, EC2A 4NE

Phone

+44 (0)7359200438

Email

Connect

  • LinkedIn
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