Quality and Regulatory Affairs (QARA)

With a combined total of more than 35 years in QARA, our expert collaborators can help you achieve your goals in getting your medical devices to market, being audit-ready and long-term strategic planning.

Submission Prep

Preparation of regulatory submissions to FDA:

  • 510(k)

  • Breakthrough Device Designation (BDD)

  • De Novo devices

  • Humanitarian Device Exemption (HDE)

  • Investigational Device Exemption (IDE)

  • PMA Annual Report or 30-Day Notice

  • PMA Supplement - 180-Day, Real Time, Panel Track

  • Premarket Approval (PMA)

  • Q-Submission

Strategies and Playbooks

  • Companion Diagnostics (CDx)
  • Investigational Device Exemption (IDE)
  • Investigational Use Only Devices (IUO)
  • Laboratory Developed Tests (LDT)
  • Research Use Only Devices (RUO)
  • Software as a Medical Device (SaMD)

Audit Preparation and Response

  • ISO:13485:2016 and Medical Device Single Audit Program (MDSAP) audit preparation and response
  • ISO:14971:2019 and ISO:9001 interpretation, audit preparation and response
  • Corrective and Preventive Action (CAPA) response development and tracking

 


Regulatory Intelligence

  • Regulatory intelligence program development
  • Focused regulatory intelligence reports

Ad/Promo

Advertising and promotion review to ensure compliance with FDA and FTC requirements

Quality Systems

  • Quality System Regulation (QSR) interpretation and application
  • Quality Management Systems (QMS)
  • Medical Device Quality Management Systems (MDQMS)
  • Electronic Quality Management Systems (eQMS)
  • Document Management Systems (DMS)

Standards Management

  • Assessment to determine applicable standards
  • Audit preparation for ISO certification
  • Cost analysis for purchase of standards for enterprise use

Registration and Reporting

■ Post-market Surveillance (PMS):

  • Medical Device Reporting (MDR)
  • FDA's Manufacturer and User Facility Device Experience (MAUDE) reporting
  • Nonconformance Report (NCR) response  

■ FDA Facility/establishment registration

■ Registration and entries into:

  • FDA's Unified Registration and Listing System (FURLS)
  • Global Medical Device Nomenclature (GMDN) Agency
  • GS1 - information standards organization
  • Global Unique Device Identification Database (GUDID) entry and follow-up on premarket entries 

Talk to us about your QARA needs. Click here to start the conversation.