Med Device Archives - Insights From Our Labs to Yours

Developing an effective reimbursement strategy – if you build it, will they come?

by Tom Hughes, Health Economics and Reimbursement Senior Principal Advisorupdated on Monday, June 7, 2021Monday, August 10, 2020

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.

Are you ready for BIMO inspections?

by Mary Kay Sobcinski, Clinical Senior Principal Advisorupdated on Monday, June 7, 2021Wednesday, June 24, 2020

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 …

Working with a CRO – tips from the sponsor’s perspective

by Myrna Little, Clinical Project Managerupdated on Tuesday, June 23, 2020Monday, June 22, 2020

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 …

Are your CERs ready for MDR?

by Meghan Swanson, Regulatory/Quality Project Managerupdated on Monday, June 7, 2021Wednesday, May 6, 2020

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 …