Doctor Operating CT Scanner
Doctor Operating CT Scanner

Dental Equipment Sterilizer
Dental Equipment Sterilizer

Doctor Operating CT Scanner
Doctor Operating CT Scanner

Doctor Operating CT Scanner
Doctor Operating CT Scanner

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Our Team

Our team at SQS Global specializes in the Global Medical device industry's Quality and Regulatory needs.  

With over 100 years of combined experience in all aspects of class 1, 2 and class 3 devices in 50 countries, we can solve any request our customers may encounter.  

Services

Serving the Medical Device Manufacturing industry for 20+ years, SQS global specializes in the major infrastructure needs of a modern company.

Quality Services:

  • QMS Management

  • EQMS implementation and Management

  • Auditing

  • ISO 13485:2016 Upgrade

  • MDSAP implementation

  • Design Quality Assurance

  • Supplier Quality

Regulatory Services:

  • FDA Breakthrough Device Designation

  • FDA Humanitarian Use Designation (HUD) / Humanitarian Device Exemption (HDE)

  • FDA Investigational Device Exemption (IDE), Early Feasibility Study (EFS), Feasibility Study(FS)

  • Regulatory Strategy - US, EU, Health Canada, Australia 

  • Current EU Medical Device Directive (MDD) / Active Implantable Medical Device Directive (AIMDD) 

  • EU Medical Device Regulation (MDR)

  • Audits:

  • US FDA, EU FQA / Design Examination, MDSAP,  Australia TGA, Brazil ANVISA

Connect with Us

WE ARE HERE TO HELP YOU DRIVE CHANGE

‹TOGETHER WE WILL SHAPE THE FUTURE.

 

 

‹TEL:

763.464.5020

‹MAIL:

Lee@SQSGlobal.net

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