Experience that Meets the Standards

RCRI experts have the training and experience required to develop quality systems for the medical devices, IVD’s, biologics and combination product industries.

Our medical device quality system professionals collaborate with all stakeholders to develop quality systems and compliance programs that work across functional areas and multiple product lines. It is our goal to ensure that the systems and programs used in product design, preclinical/clinical testing, manufacturing, and marketing are aligned and meet established standards.

We strive to develop medical device quality systems that meet or exceed global regulatory requirements and will work well as you add markets and products to your portfolio. We understand global requirements.  We can design quality systems that comply with U.S. FDA regulations as well as those of the European Union, China, India, Japan, Canada, and Australia.

Quality Systems

RCRI offers comprehensive quality services and develops and implements systems that conform to a variety of standards and regulations including:

  • Quality Systems Regulations (QSR)
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practice (GMP)
  • Good Tissue Practice (GTP)
  • International Organization for Standardization (ISO)

RCRI develops and implements:

  • SOP systems and instructions
  • Document and data control systems
  • Design control and risk management procedures
  • Employee training programs
  • Vendor/subcontractor assessment systems

Audits

RCRI conducts gap analyses of existing quality systems and compliance throughout the product life cycle. We also help you prepare for audits or conduct various types of internal and external auditing including:

  • ISO 9001/13485
  • Good Laboratory Practice (GLP)
  • Quality System Regulations (QSR)
  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)
  • 21 CFR Part 11 (FDA accepted electronic signatures of documents)
  • Clinical study audits
  • Due diligence audits
  • Biomedical monitoring audits (BIMO)
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Regulatory and Clinical Research Institute

5353 Wayzata Boulevard, Suite 505, Minneapolis, MN 55416-1334 USA | info@rcri-inc.com | 952.746.8080

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