Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

Maria

Legacy Devices (MDD CE marked devices)

Navigating the transition from MDD to MDR for Legacy Medical Devices, medical devices with CE marking under MDD. Check the information!

Maria

BioCat webinar

Explore health product trends, innovations, and success strategies in our webinar, "Opening Doors to Health Product Opportunities."

Maria

Medical device and IVD classifications

EU MDR and IVDR: Classifications & QMS are keys to compliance. Navigate changes for safer, effective medical devices in the EU

Soledad

Harmonizating the QSR CFR 820 with ISO 13485:2016

Navigating the Transition Taken from Brian Newbery, Founder of Fast-Track QMS Consultants As we enter a new era in the regulatory...