Regulatory Strategy & Submissions
China: NMPA and the New Medical Device Regulations
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New Edition of ISO 14155 Expected Shortly
In April 2020, the voting on the third edition of ISO 14155 took place, and the new revision is currently...
EU Medical Device Regulation 2017/745 – First Formal Amendment, Delaying Date of Application
On 24 April 2020, the first formal amendment to the EU Medical Device Regulation (MDR) was published in the Official...
Post-market surveillance under a “522 order” — why, what, and how?
Company X has gained 510(k) clearance for their new heart valve and was notified by the Food and Drug Administration...
Medical apps under the new European MDR
Worldwide, one out of every three internet users currently monitors their health or fitness using an app. This was shown in...
Clinical Evaluation Plan – The Start of All Clinical Evaluations
As manufacturer or developer of a medical device, you may already have experienced that providing enough clinical evidence that your...
Have You Considered an EUA for Your Diagnostic Test?
In certain emergencies, like the current COVID-19 pandemic, the FDA can quickly issue an Emergency Use Authorization for diagnostic tests...
Is the FDA’s EFS Program Right for Your Medical Device?
What is an Early Feasibility Study (EFS)? The FDA created its EFS program to help increase patient access to new,...
Global Regulatory Update: A Trend towards Harmonization and Enforcement
Gaining access to the global medical device market can be challenging because regulatory requirements are rapidly changing. Medical device manufacturers must be well acquainted with…
Environmental and Social Considerations for Medical Devices
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