COVID-19 Support Services for the Medical Device Industry

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.

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

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.