Expert Insights

Explore practical guidance to help medical technology teams reduce risk, make informed decisions, and bring life-changing products to patients faster.
A Focus on the Challenges with Utilizing Remote Monitoring in Patient Healthcare
illustration representing the future of healthcare

A Focus on the Challenges with Utilizing Remote Monitoring in Patient Healthcare

March 28, 2023 5 min read
Team NB Position Paper Submission of Technical Documentation Highlights
man pointing to document icon

Team NB Position Paper Submission of Technical Documentation Highlights

March 16, 2023 5 min read
FDA Seeking Sources for Medical Device Active Surveillance System – Understanding FDA’s Request
graphic of connecting people

FDA Seeking Sources for Medical Device Active Surveillance System – Understanding FDA’s Request

March 10, 2023 4 min read
New Brazil Regulation for Medical Devices Now In Effect – Steps to Take
Brazil flag

New Brazil Regulation for Medical Devices Now In Effect – Steps to Take

March 9, 2023 3 min read
New Guidance Released on EU MDR Vigilance Terms and Concepts
blocks spelling out guidance
EU

New Guidance Released on EU MDR Vigilance Terms and Concepts

March 2, 2023 5 min read
EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?
european union flag flying next to building
EU

EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?

March 2, 2023 3 min read
US Reimbursement for Medical Device and IVDs – What Startups Should Know
reimbursement paper next to calculator

US Reimbursement for Medical Device and IVDs – What Startups Should Know

February 10, 2023 3 min read
Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR
doctor using tablet in medical room
EU

Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR

February 2, 2023 3 min read
VALID Act Fails to Pass – What to Expect for the Future of LDT Regulation
circle with slash through it over the valid act next to gavel

VALID Act Fails to Pass – What to Expect for the Future of LDT Regulation

January 23, 2023 2 min read

Patients Are Waiting.

Every submission, study, inspection, and commercialization decision moves a patient closer to the technology they're waiting for. Partner with Medicept to navigate every milestone with clarity, continuity, and confidence.