Meeting your specific quality
and compliance needs


The Regulatory & Clinical Research Institute, Inc. experts have the training and experience required to develop quality systems for the medical devices, IVD’s, biologics and combination product industries.

Our quality professionals collaborate with regulatory and clinical colleagues 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 quality systems that meet or exceed global regulatory requirements that will work well as you add markets and products to your portfolio. We understand global requirements and can design quality systems that comply with U.S. FDA regulations as well as those of the European Union, 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 the following:

  • Quality systems, SOPs, and work instructions
  • Good Laboratory Practice (GLP)
  • Current Good Manufacturing Practice (CGMP)
  • Current Good Tissue Practice (CGTP)
  • 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
  • GLP
  • QSR/CGMP
  • GCP
  • 21 CFR Part 11
  • Clinical study audits