Researchers Develop the New ML Tool for Predicting Progress in COVID-19 Patients
In the current Digital Age, we hear the term Machine Learning (ML) in almost every domain. But what exactly is ML? Simply, ML is a way of pr...
The COVID-19 pandemic has introduced unprecedented challenges to the medical device and life-sciences industry. From PPE shortages, remote audits, delays in regulatory processes, and much more. EMMA International has stayed on top of the ever changing quality and regulatory landscape amidst the global public health emergency and has compiled the following resources to keep the life-science industry informed, to ensure life-saving products get to market, and stay on the market.
If you need help navigating through COVID-19 for your medical product, EMMA International is ready to help 24/7. Contact us at 248-987-4497 or email info@emmainternational.com to get connected with our team of experts today!
We’re here to help with all your COVID-19 needs. Get in touch below.
In the current Digital Age, we hear the term Machine Learning (ML) in almost every domain. But what exactly is ML? Simply, ML is a way of pr...
The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing further guidance on the exp...
The FDA revised its guidance document ‘Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Me...
COVID-19 vaccines have now been approved for a few weeks, and nearly 2 million people in the United States have received their first dose of...
In a historic move on Friday afternoon, the FDA granted the first Emergency Use Authorization (EUA) to Pfizer and BioNTech’s COVID-19 vacc...
Health Canada released a notice for the stakeholders of the medical device and drug industry to help them understand the tenure of the inter...
Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due to the COVID-19 pandem...
Health Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shie...
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-1...
Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved....
The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World ...
As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic ...
Internal audits are a critical activity for every medical device firm. Not only are they mandatory per 21 CFR 820.22 and Clause 8.2.4 of ISO...
Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at it...
The EU Compliance and Enforcement Group (COEN) recently released a new guidance document that provides information to the industry on how to...
I think I can speak for most people when I say that viable treatments and vaccines are desperately needed at this point to overcome the COVI...
FDA released a guidance document on Monday in the form of a question and answer format to help the industry understand the implications of t...
FDA has already issued temporary policies on how it regulates PPEs and various other covid-19 essential medical supplies during this public ...
The FDA has recently released a new emergency use authorization (EUA) template aimed at developers of at-home sample collection kits for COV...
Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products to streamline the approach ...
In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical De...
As medical device firms adjust to the new normal in light of COVID-19 hurdles, the FDA continues to issue guidances and relax regulatory req...
In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will allow for clinical laborator...
Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, i...
The effects of COVID-19 have been widespread across different parts of the medical device world, but the Digital Health sector has seen the ...
Back in Mid-March, when the COVID-19 pandemic was starting to take off in the US, the FDA issued a policy that allowed antibody tests to ent...
COVID-19 has severely disrupted the medical device supply chain. Device manufacturers are typically not required to report shortages of devi...
The COVID-19 pandemic has had a broad and prevalent impact on the FDA and “normal” medical device life as the industry knows it. Everyth...
In Europe, medical devices are regulated under the Directive 93/42/EEC—the “Medical Devices Directive” (MDD) which is annulled by the ...
Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help prevent shortages of medi...
The COVID-19 pandemic has caused mass shortages of ventilators and PPE globally, but now healthcare workers are starting to see the effects ...
In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving the EU MDR deadline, whi...
Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipme...
Are you a manufacturer and want to help with the COVID-19 Pandemic? We invite you to attend our upcoming webinar to learn more about FDA’s...
Health care facilities are facing shortages of medical equipment, drugs, PPEs and essentials such as hand sanitizers. Hand sanitizers were t...
Amid the pandemic situation, and states’ officials struggling to secure Personal Protective Equipment, FDA released a guidance document th...
On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of COVID-19 treatments. With over...
As COVID-19 cases surge across the country, the health care industry is preparing itself to face ventilator shortages. There are fewer than ...
With the number of confirmed COVID-19 cases now exceeding 200,000 globally, the WHO and many other international government agencies are eit...
With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the medical device industry....
Amid the COVID 19 pandemic, with 10 states in the US declaring a ‘state of emergency’, foreign and international travel restrictions, FD...
As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global health organizations have had ...