Resources


[fa icon="laptop"] On-Demand Webinars

R&Q Intelligence Series webinars are held live on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees.

Slides, recordings, and Q&A are made available to all registrants.

  Preparing your CER for MDR: Gathering Clinical Evidence
(upcoming - registration open!)

  EU MDR / CER Portfolio Planning
  MEDDEV 2.7/1 & CERs: Know the changes and what to do.
  EU MDR: Assessing the impact and next steps.
■  Risk-Based Approach to ISO 13485:2016: Risk considerations and implementation.
  Cybersecurity: Regulatory and quality ramifications.
■  MDSAP: Can I really get down to just one audit?
■  ISO 13485:2016 and ISO 9001:2015: A Risk-Based Approach to Your QMS Implementation

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[fa icon="folder-open-o"] Case Studies

These case studies succinctly demonstrate how R&Q applied our unique expertise to tackle a client's challenge, implement a competent solution, and demonstrate real results.

Subscribe to our blog to be notified when new case studies are available and view all of our services here.

  Clinical Evaluation Report (2 of 2)
■  Acquisition Regulatory Assessments
  Supplier Quality Remediation
  Process Validation
  CAPA Remediation
  Human Factors and Usability
  QMS Integration
  Clinical Evaluation Report (1 of 2)
  Regulatory Strategy
  Design History File Remediation
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[fa icon="book"] White Papers

R&Q is a thought leader in regulatory and quality for medical devices, both in understanding new and emerging trends and defining new ways of maintaining compliance.

Our free white papers provide timely and practical information to readers as part of our mission of sharing best practices across the industry. If you have have specific questions about any white paper topic, please contact us.

 Managing An Adverse FDA Inspection
  510(k) Submissions
  Regulatory Strategy
  Warning Letters
  Unique Device Identification (UDI)
  Risk and Usability
  CAPA
  Recalls
  TPLC Reports