You and your team have been working hard to gain approval and successfully launch your device. However, you may be forgetting an important consideration for market success: reimbursement.

Insights From Our Labs to Yours
Labcorp Drug Development Blog
You and your team have been working hard to gain approval and successfully launch your device. However, you may be forgetting an important consideration for market success: reimbursement.
The time to answer “yes” to the question “are you ready for an FDA Bioresearch Monitoring Program (BIMO) inspection?” is not near or at the end of a trial……it’s at the beginning. And in the middle. And of course, at the end. Inspection readiness is an ongoing and vital component …
Congratulations! You’ve just selected the contract research organization (CRO) that best fits your goals, timeline, budget and philosophy. You’re confident that the project team, study and company will be successful! What’s next? Whether you are expecting a “turn-key” solution from your chosen CRO or are partnering with them for a …
Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex. The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. Now, even with the all but official postponement of …