Fast-Track Your Medical Device

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Fast-Track Your Medical Device

The U.S. Food and Drug Administration (FDA) has been accelerating requests for Emergency Use Authorization (EUA) of Medical Products to enhance the fight against COVID-19. Leading the way are companies developing diagnostic tests for SARS-CoV-2. Among these are well-known manufacturers of medical devices and diagnostic tools such as Thermo Fisher, Abbott Laboratories, Cepheid and Roche Molecular Systems.

In order to accelerate time to market, these companies are mobilizing both medical and engineering professionals to ensure they meet both the immediate needs of fighting the pandemic, and the long term requirements of maintaining FDA approved products. This situation is driving demand for professionals who are well-versed in:

  • Class I, II, III medical devices
  • Quality Systems (QS) Regulations
  • 510(K) and PMA (Pre-Market Approval)
  • ISO 13485

To say the least, these are specialized skills that are needed in a very specialized field. Before the pandemic, these skilled professionals were already in high demand. The urgency of the pandemic has only exasperated the shortage of professionals in the following areas:

RESEARCH AND DEVELOPMENT (R&D):

  • Mechanical Engineers
  • Electrical Engineers
  • R&D Technicians, Test Technicians

MANUFACTURING AND QUALITY:

  • Manufacturing Engineers
  • Quality Assurance
  • Quality Control
  • Packaging Engineers
  • Manufacturing Technicians

COMPLIANCE AND DOCUMENTATION:

  • Regulatory Affairs Specialist, Managers, Auditors
  • Risk Compliance Auditors
  • Technical Writers

Solopoint Solutions have developed a strong network of engineering professionals in the medical device and biotech industries. These professionals are well familiar with the demands and rigors of developing and commercializing critical products in a highly regulated industry. Let’s join forces!

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