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[FEATURED] Does EU Regulation Of 3D-Printed Implants Expose Gap In MDR Regime?
“Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU […]Read More[FEATURED] EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis?
“Since the EU’s new Medical Device and IVD Regulations took effect in May 2017, progress toward implementation has […]Read More2018 – Good For The Device Industry, Good For Patients, Good For FDA
Read through an interview with Maureen Mulvihill of Actuated Medical, Inc. as she shares her educated predictions on […]Read MoreEU MDR and Clinical Evidence: What You Need to Know
“One of the key objectives of the new EU MDR is to ensure a high level of health […]Read More[FEATURED] New 510(k) Modifications Guidance May Prompt New Submissions
US FDA has made at least nine changes releasing a final 510(k) modifications guidance on Oct. 24. This […]Read More