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.

 NEW: Wait, what? That's a combination product? How to spot a medical device in your portfolio and what to do about it.
(Sept. 25 - Register here)
 NEW: Understanding EU MDR and the Roadmap to Compliance: A guide to EU MDR for small companies.
(Oct. 23 - Register here)
 NEW: Economic Operators: Are your importers, authorized representatives, and distributors ready for EU MDR? Are you?
(Nov. 27 - Register here)
 CERs – Tips, Tricks, and Lessons Learned
 EU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it.
 Risk Management Updates: What to do with your risk management process to meet the MDR.

 Technical Documentation for EU MDR: How much remediation will you need to do?
  QMS for EU MDR: Does your quality system meet the additional requirements?
  Preparing your CER for MDR: Gathering Clinical Evidence
  EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements.
  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


 

[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
■  Clinical Evaluation Report (1 of 2)
■  Regulatory Strategy
■  Design History File Remediation
  • Case Study Clinical Evaluation Report Excerpt
  • Acquisition Medical Device Regulation Assessments Case Study
  • Case Study: Supplier Quality Remediation Services
  • Case Study: MedDev Regulation Process Validation
  • Case Study: CAPA Post-Market Regulatory & Remediation Services
  • R&Q Case Study: Usability Engineering
  • R&Q Case Study Clinical Evaluation Report Data
  • R&Q Case Study: Regulatory Strategy for Medical Devices
  • R&Q Case Study: DHF Remediation Services

 

[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