Medical Device Compliance Consulting for Global Markets

RCRI’s medical device compliance consulting takes into account a myriad of factors that make for a successful market launch and throughout commercialization.  Whether you need medical device, IVD, or biologics compliance consulting, RCRI offers consultants experienced with both the U.S. FDA and other international bodies. Our consultants offer expert insight and guidance for smooth, efficient market introductions.

Global Compliance – with Less Effort

Go global with less effort. Let’s talk today about how RCRI can help your next compliance project get off to a smooth start and a profitable finish.

Comprehensive Medical Device Regulatory and Quality Systems Compliance Plans

A medical device regulatory and compliance plan may be quite simple – or very complex. It depends upon the market, the innovation, and the needs. At RCRI, we collaborate with you to understand the nuances of your innovation and offer flexible medical device regulatory and compliance plans to help you assess multiple aspects of your product launch. RCRI conducts gap analyses of existing quality systems and compliance throughout the product life cycle.

Services include:

  • Quality systems SOPs, and work instructions
  • Document and data control systems
  • Design control and risk management procedures
  • Employee training programs
  • Vendor/subcontractor assessment systems
  • Clinical study audits
  • Due diligence audits
  • Biomedical monitoring audits (BIMO)
  • Change control and design process (appropriate documentation, justification, and testing to support the change and determination if you need regulatory approval of the change).

Audits are conducted to the following standards:

  • International Organization for Standardization (ISO) 9001/13485
  • Good Laboratory Practice (GLP)
  • Quality System Regulations (QSR)
  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)
  • Good Tissue Practice (GTP)
  • 21 CFR Part 11 (FDA accepted electronic signatures of documents)

Contact us today for an appointment and consultation.

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Regulatory and Clinical Research Institute

5353 Wayzata Boulevard, Suite 505, Minneapolis, MN 55416-1334 USA | | 952.746.8080

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