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Morrisville, N.C., company provides resources and direction for medical device authorization under FDA Emergency Use Authorization Guidance.

Press Release



updated: Apr 29, 2020 13:45 EDT


MethodSense, a medical device consulting firm working with manufacturers, inventors and investors around the world to bring products to market and achieve business success in the U.S. and E.U., has launched its EUA Resource website.

The site is now available to assist those in the medical device community planning to submit device authorization requests under the FDA Emergency Use Authorization Guidance in response to the COVID-19 outbreak.

“The Emergency Use Authorization Guidance exists to help accelerate the process for inventors, engineers and manufacturers in the medical device field to take part in combatting this devastating situation,” says Rita King, CEO of MethodSense. “We are here to help.

“We created the EUA Resource website using our extensive EUA submission experience working directly with the FDA. This resource combines our 20 years of compliance proficiency with numerous experts in the medical device field to answer our clients’ questions about the EUA Authorization process. MethodSense can then walk them through the steps to FDA approval for a device.”

The EUA Resource Site uses MethodSense’s proprietary software LuminLogic (www.luminlogic.com), a thin client, web-based and highly configurable Software as a Service application intended to support regulated content. The application meets compliance and auditability requirements of 21 CFR Part 11. Numerous client on-site inspections by FDA auditors assure that LuminLogic is maintained within the desired level of compliance.

The EUA Resource includes secure login access for qualified requesters; FAQs with answers from a pool of volunteer industry experts, including FDA staff; links to important informational site pages on FDA.GOV, HHS.GOV, AAMI.ORG and others, and downloadable documents, including FDA Guidance supporting the EUA, checklists and other tools.

“Whether working with an existing product currently FDA-approved for another purpose with the potential to fight the Coronavirus, or a new product development, our purpose is to help our clients help others and for all of us be part of the solution – together,” says Russ King, president of MethodSense.

Medical device companies and manufacturers interested in an EUA may request access to the EUA Resource website by email. Industry experts wishing to join the pool of professionals volunteering as Site Curators may send an email with “Curator” in the subject line.

For more information about MethodSense’s EUA Resource, visit www.methodsense.com, email [email protected] or call 919.607.4775.

MethodSense is a medical device and combination product consulting firm working with manufacturers, inventors and investors around the world to bring products to market and achieve business success in the U.S., E.U., Canada and other markets. Unmatched regulatory expertise and our purpose-built LuminLogic software platform uniquely position MethodSense to develop effective strategies for quality compliance and regulatory submissions, from initial filing to product launch and on-going quality and regulatory support. MethodSense has the answers. www.methodsense.com

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Contact:

Russ King, President
O: 919.313.3962
C: 919.607.4775
email: [email protected]
www.methodsense.com

Source: MethodSense