SunState MedDev Consulting

SunState MedDev ConsultingSunState MedDev ConsultingSunState MedDev Consulting

SunState MedDev Consulting

SunState MedDev ConsultingSunState MedDev ConsultingSunState MedDev Consulting
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Experienced Medical Device Consulting

Experienced Medical Device ConsultingExperienced Medical Device ConsultingExperienced Medical Device Consulting

Helping you to achieve your Quality and Regulatory Goals 

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Welcome

We are all about Quality!  Medical Devices and Combination Products.  Quality Management Systems.  ISO Certification.  Global regulatory compliance and more 

Let us help!

What We Do

Quality Systems

Global Regulatory Affairs

Auditing & Assessment

  • Process and Procedural Development
  • Process Flowcharting 
  • QMS Risk Management Programs 
  • Supplier Management 
  • CAPA & Complaints 

Auditing & Assessment

Global Regulatory Affairs

Auditing & Assessment

Experienced Professional Auditing for all aspects of QMS & Regulatory Evaluation 

  • ISO Assessment 
  • MDSAP Readiness 
  • FDA Preapproval Inspection 
  • Supplier Audits 
  • Supply Chain Assessments 

Global Regulatory Affairs

Global Regulatory Affairs

Global Regulatory Affairs

  • ISO 13485: 2016
  • ISO 9001: 2015
  • MDSAP 
  • US FDA 
  • Health Canada 
  • Australia 
  • Brazil 
  • Japan
  • European Union 
  • UK (Brexit)

Privacy Policy

You have the right to know what we do with the information you provide to us, names, contact phone number, and the details of your requests and needs.  We only collect information  needed to assist you.   We only share information when approved by  our clients.  We do not  sell customer information of any kind.

Copyright © 2021 SunState MedDev Consulting - All Rights Reserved.

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