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The need for medical devices is increasing in Europe because of the aging and growing population, emerging market expansion, and the rising prevalence of chronic diseases. This increase has necessitated manufacturers to develop and market medical devices that range from simple to complex. However, recent incidents, including the breast implant crisis and the hip replacements, have now prompted European Commission to increase regulatory oversight, expand clinical evidence requirements, increase requirements for Medical Device and IVD manufacturers and intensify supervision of Notified Bodies. Among the most significant of these are the regulations on Medical Devices (EU MDR) and in-vitro diagnostics (EU IVDR).

Stark Associates aim to assist global Medical Device and IVD manufacturers to prepare and comply with MDR and IVDR. Stark Associates offers a wide range of services from gap analysis to MDR Compliance. We will deliver a comprehensive gap analysis report detailing deficiencies, with recommendations on how to fix them and the order in which you should address them to the regulatory body.

Stark Expertise:
Regulatory strategy
  • Regulatory strategy
  • Establishing scope
  • Milestones/timelines
  • Budget and resource planning
  • Device classification
  • Identifying applicable standards and regulations
  • Determining approach for regulatory submissions
Gap Assessment
  • Product classification
  • CE Technical Documentation
  • Labeling
  • Risk management file review
  • Clinical evaluation reports
  • Quality management system (QMS)
Regulatory Documentation
  • Design History Files (DHF)
  • Device Master Record (DMR)
  • Technical File/Dossier preparation
Standards compliance
  • ISO 13485
  • ISO 14971
  • CE Marking
Compliance services
  • Labeling
  • Quality Management System
  • QSR compliance
  • Unique Device Identification (UDI)
Post-market activities
  • Adverse event reporting
  • Field Safety Corrective Actions (FSCAs) report
Stark Advantages:
  • On-time delivery of regulatory services with great quality.
  • Dedicated Regulatory professionals with relevant skill sets to provide Medical Device and IVD compliance and submission services.
  • Successful regulatory submissions for diverse class of devices ranging from implants to thermometer.
  • Well-versed in working with various stakeholders like clinical research, clinical data management, biostatistics, engineering, medical and product quality complaints teams to deliver documents.