Our Latest News & Blogs

What You Need to Know about FDA’s Draft Guidance on Writing Test Reports

The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in premarket submissions in May 2018. As a draft guidance, the FDA is seeking comment from the industry prior to finalization.

 

Leveraging 3D Printing For Small Hospitals and Device Developers

The Society of Manufacturing Engineers’ (SME) 2018 Annual Report took a deep dive look at medical additive manufacturing, more commonly referred to as 3D printing.

 

What You Missed Last Month July Edition

Lots has happened in the MedTech Industry since last month. New EU Medical Device Regulations continue to pose as a threat to additive manufacturing, the FDA is urging companies to go paperless, and there has been a recent development in 3D printing that will allow biological tissues to be created. Here is a short overview of what you missed in the month of July:

How GDPR Applies to Medical Devices

With the European Union’s General Data Protection Regulations (GDPR) going into effect May 2018, much of the attention has been on its impact on Internet websites and applications that gather personal information, but it also affects makers of medical devices that offer goods or services to, or monitor the behavior of EU data subjects, according to the EU GDPR organization.

 

 

 

 

 

 

British Researchers Report First 3D Printed Human Corneas

With little fanfare in the media, researchers announced that they had successfully used 3D printing to produce the first human corneas for transplant.

 

 

 

 

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