REGULATORY + QUALITY

Regulatory affairs

Medical device companies looking to enter the global marketplace require a solid regulatory strategy. When developing a new product, it’s imperative to understand the regulatory compliance requirements in all geographies of interest. RCRI has extensive worldwide experience with regulatory agencies, and provides regulatory consulting to help you plan your market approach from conception to completion, saving you time, money and effort.

Regulatory consulting begins with the end in mind

We begin all projects with our unique integrated approach.  With our depth and breadth of regulatory experience, we examine all aspects of regulatory compliance and strategy, to help you uncover potential strategic regulatory risks. RCRI offers our clients the advantage of our experience across multiple technologies and therapeutic areas. We’ve cultivated novel, targeted strategies over the years to help our clients achieve regulatory approval in multiple markets.

RCRI’s regulatory compliance consulting process is more efficient because of our innovative thinking, comprehensive and thorough research, and insights only years of experience can offer.

CAPABILITIES

  • Regulatory Compliance Consulting
  • Regulatory Strategy
  • Project Management
  • Device Claims Development
  • Labeling
  • Design Control
  • Regulatory Submissions: Preparation and Negotiation
  • Registration and Licensing Support
  • Clinical Evaluation Reports (CERs)
  • Quality Systems and Compliance
  • Quality System Audits
  • Risk Management

“I’ve been working with a PA, and she has been fantastic…very responsive, got up to speed on our product quickly…has a great rapport with our reporting director. I give her very high marks.”

– VP, Engineering (Start-up drug delivery system manufacturer)

Quality Systems. Quality Support.

RCRI also provides comprehensive Quality Systems support for FDA quality system regulation (QSR) and ISO compliance. We support our clients with:

  • Integrating regulatory and quality strategies using risk-based approaches 
  • Designing and implementing quality systems
  • Maintaining innovative quality strategies, flexible enough to address specific device nuances and designed to grow along with the device during the entire product lifecycle
  • Researching and understanding regulatory body hot buttons to provide proactive risk-mitigation strategies to avoid regulatory sanctions.

From Fortune 100 companies to start-up innovators, our advisors have assisted with establishing design controls, performing audits and addressing compliance gaps. No matter your size, we can scale the quality system effort to your goals, products, and culture.

RCRI is your Expert regulatory consulting and quality systems partner.

RCRI Regulatory Affairs services brochure    DOWNLOAD

CASE STUDY:

Lessons learned from missing the mark with FDA hot buttons

A surgical device manufacturer pursued their first 510(k) clearance for their CE Marked product but was faced with considerable challenges during the FDA review process. 

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