COVID-19 Support Services for the Medical Device Industry

Our first priority is protecting the health and safety of our colleagues and clients while still providing valuable public health services.

We want you to know that our team is here to help you and the health care industry through these uncertain and fast-moving times.

Our team has spent their careers building contingency plans for worst-case scenarios. The experience and formal training of our professionals -- including former regulators, Ph.D.s and physicians — has enabled us to quickly assess and respond to the needs of the medical device industry and provide regulatory consulting, eLearning and virtual training services.

We provide a wide range of virtual and remote auditing, regulatory consulting and training services aimed to help medical devices and IVD companies continue to operate during the COVID-19 pandemic.

Regulatory Consulting

We provide regulatory consulting services to:

  • Assist public health organizations, governments, and manufacturers in developing patient safety communications, applying risk communication strategies to elicit behavioral change
  • Assist manufacturers and regulators with emergency preparedness and supply chain resilience for providing medical equipment including ventilators, diagnostic tests, personal protective equipment (PPE) including the much-needed gowns and masks for infection control, and essential services to international health care institutions
  • Design and execute supply chain resilience strategies to ensure that COVID-19 risks are understood, controlled and managed
  • Assist in new product development, risk management and regulatory clearances/approvals for medical devices in U.S. and EMEA region that can support COVID-19 efforts
  • Provide emergency assessment of IVDs and medical devices
  • Emergency Use Authorization (EUA) Preparedness and Submission
  • Post EUA Documentation
  • Provide clinical services and clinical evaluation reports
  • Develop software
  • Review technical documentation

eLearning and Virtual Training

When in-person learning or training is not possible, we offer options to keep staff up to date:

eLearning: Our full range of eLearning courses for the medical device industry can be customized to meet your organizational needs. Now is the perfect time to educate your entire workforce, groups or individual employees in topics relevant to their job role.

Virtual training: With many more of us working together remotely, we are now offering our training programs virtually with experts to guide you in an interactive and engaging virtual classroom. Our instructor-led training can be customized to your organizational requirements – we are already working with our clients to meet their exact needs.

Do not postpone the development of your staff; maximize their contribution to the business and improve your competitive edge. Our virtual training courses complement our 2020 public training schedule.

News and Events

NSF’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.

March 2023 Pharma News Update

March 1, 2023

The U.S. NIST has developed a framework to better manage risks to individuals, organizations and society associated with artificial intelligence (AI).

March 2023 Medical Device and IVD News Update

March 1, 2023

Welcome to our March Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.