Archive for the WCS News Category

How the COVID-19 Crisis Exposed Weakness in the International Regulatory Supply Chain

How the COVID-19 Crisis Exposed Weakness in the International Regulatory Supply Chain The COVID-19 crisis has been a substantial tragedy. It has devastated the health of communities, economies, and our collective sense of normalcy. For medical device companies, the crisis has triggered an assessment of the resiliency…

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Notified Bodies

Even though the EU MDR was postponed until May 2021, the dwindled-down list of Notified Bodies suggests Regulatory Affairs professionals might not want to kick the can too far down the road.  For those looking at the upcoming IVDR, the situation is even bleaker. The IVDR has…

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3 Ways COVID 19 Impacted the Global Health Industry

COVID 19’s Impact on the Global Health Industry In the wake of COVID-19, the global health industry has been put to the test. Age-old protocols were threatened as social distancing and illness threatened to wreak havoc on companies. While nearly all industries have had to work to…

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Latest EUMDR Updates

Latest EUMDR Updates In response to the COVID-19 pandemic, EU regulators proposed a one-year delay on the new EU MDR, to May 2021. The EU MDR Date of Application has officially been extended until May 2021. While most Regulatory Affairs and Quality Control professionals are rejoicing in…

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Arthrex: Manufacturing Face Shields for Healthcare Workers

Arthrex: Manufacturing Face Shields for Healthcare Workers Amidst COVID-19 Crisis The panic at the spread of the dangerous virus caused a spike in hand sanitizer, toilet paper, and unfortunately, extremely crucial face masks. With this horrifying scarcity looming over our healthcare providers, companies and communities alike are…

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Abbott Launches a Five Minute Test to Detect COVID-19

Abbott Launches a Five Minute Test to Detect COVID-19 On March 27th, Abbott announced that the FDA had approved and declared their COVID-19 detection test the fastest on the market. At the crippling rate this is spreading, a quick test is more critical now than ever. –…

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BD Seeks Emergency FDA Approval for a Two-Hour COVID-19 Test

Times Article: “Becton Dickinson Seeks Emergency FDA Approval for a Two-Hour Coronavirus Test”  On March 17th, Times magazine released an article informing the public that Becton Dickinson (BD) is seeking emergency FDA approval for a two-hour coronavirus test. If approved, this would save hospitals up to two…

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COVID-19 UPDATE

COVID-19 UPDATE July 8th Update The State of Maryland has announced a Phase II plan, and we are working diligently in the office to serve you! Thanks to the selfless service of Healthcare workers and Marylanders for staying home and practicing social distancing. The State of Maryland…

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EUMDR 2017/745

Europe’s New Medical Devices Regulations 2017/745(MDR) deadline is finally here! European Union Medical Device Regulation 2017/745 deadline approaches on May 26, 2020. Medical device companies must comply with the new regulations to maintain market access and mitigate risk. Medical devices and implantable objects have not faced the…

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US Apostille & Embassy Consular Legalization

US Apostille & Embassy Legalization document requirements: the often overlooked part of shipping products internationally.

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