Working Remotely Through COVID-19

by Madison Green | Mar 25, 2020 | CDC, Coronavirus, EU MDR, OQA, QMS, Quality Systems, Requirements

With the number of confirmed COVID-19 cases now exceeding 200,000 globally, the WHO and many other international government agencies are either recommending or enforcing a “shelter in place” order to slow the spread of the disease.¹ This is an unprecedented time for the medical device and other life-science industries as they must adapt to 100% remote work quickly. With the EU MDR deadline still set for May 26^th, the global shortage of medical devices, and other obstacles still to come, the medical device industry can’t afford to skip a beat.

EMMA International’s Outsourced Quality Assurance (OQA) Program® can oversee your Quality Management System (QMS) and is a flexible and efficient way to outsource all your QA/RA needs 100% remotely. The focus right now is getting all critical medical devices to the hospitals and patients that need them, which means QA/RA work will only continue to ramp up in the face of this public health emergency. As medical device institutions face travel restrictions, the challenge of adapting to remote work, and other upheavals, EMMA International’s OQA Program® can step in and ensure seamless integration.

In this new era of working from home, having expert talent available anytime is crucial. EMMA’s OQA Program® has an unparalleled deployment speed and scalability, with a team of Quality and Regulatory experts ready to jump in. Our OQA Program® ensures that whatever your needs are, we have a solution tailored to you which includes:

A team of internal experts with the experience and credentials suited for any quality or regulatory needs.
Availability when and where you need it.
Proven project management expertise, to ensure no matter the situation you won’t miss a deadline.
Flexibility to the ever-changing priorities and regulations, especially surrounding COVID-19.

The COVID-19 pandemic is forcing the medical device industry to re-think how they can support their QA/RA functions. With an unprecedented time still ahead of us, give EMMA International a call at 248-987-4497 or email info@emmainternational.com to see how we can suit our OQA Program® to fit your needs through it.

To learn more about what our OQA Program® has to offer, visit https://emmainternational.com/outsourced-quality-assurance/

¹WHO (March 2020) Coronavirus disease 2019 situation report – 59 retrieved on 03/20/2020 from: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200319-sitrep-59-covid-19.pdf?sfvrsn=c3dcdef9_2

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.