Services

Quality Management Systems

Quality Management Systems (QMS)

  • We can collaborate with you to develop, implement, and maintain your Quality Management System for compliance to global regulatory requirements.
  • Quality System Development and Creation of Applicable Procedures
  • Quality System Auditing under the following requirements:
    • ISO 9001:2015
    • ISO 13485:2016
    • FDA Quality System Regulations (QSR)
    • MDSAP (Australia, Brazil, Canada, United States, Japan)
    • EUMDR 2017/745
Regulatory Affairs

Regulatory Affairs

  • Regulatory Standards Assessment / Gap Analysis
  • Regulatory Review of Labeling
  • Regulatory Review of Technical Documentation
Quality Assurance

Quality Assurance

  • Facility Qualification / Manufacturing Transfer Facility Qualification
  • Internal Audits
  • Regulatory Body Pre-Audit Preparation
  • Supplier Evaluation / Audits
  • Internal Auditor Training

About us

At SH Compliance & Service Consulting, we take our clients as our business partners. Our work is performed with high quality to benefit your business. Our process is built on a relationship based of excellence, integrity, and always trying to give the best performance for our clients. We will maintain regulatory expertise to ensure our service takes your business where it needs to be. We can do our service in English or Spanish.

Schedule a Consultation

Contact

Ruth Hansen

(651)-964-5235

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