Device Archives - Insights From Our Labs to Yours

Fix, replace or augment: Key considerations for rescue or transition studies in medical device clinical trials.

by Suzanne Carroll | Vice President & General Manager Medical Device and Diagnostic Developmentupdated on Monday, January 31, 2022Thursday, November 18, 2021

Clinical trials are demanding, rigorous and time-sensitive. This is especially true for medical device development where the protocols, patient selection or surgical interventions may be highly specific. The demands on all parties – developer, Contract Research Organization (CRO), principal investigator, site staff and participants – are high, so it is …

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 …

EU MDR and IVDR implementation and deadlines – Proposal for EU MDR application delay

by Liliana Omar, Regulatory and Quality Project Directorupdated on Tuesday, May 26, 2020Thursday, May 28, 2020

The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, …

GDPR: What is it and what does it mean for your clinical studies: Part II

by Mary Kay Kessinger Sobcinski, RN, BSN, MHA, Senior Clinical Principal Advisorupdated on Monday, June 7, 2021Tuesday, May 26, 2020

This two-part blog serves to summarize our Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by Medical Device and Diagnostic Solutions through a review of the GDPR …

GDPR: What is it and what does it mean for your clinical studies: Part I

by Mary Kay Kessinger Sobcinski, RN, BSN, MHA, Senior Clinical Principal Advisorupdated on Monday, June 7, 2021Tuesday, May 26, 2020

This two-part blog serves to summarize the Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by our Medical Device and Diagnostic Solutions through a review of the …

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 …

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Labcorp delivers unmatched COVID-19 diagnostic and therapeutic applications

by Labcorpupdated on Monday, June 7, 2021Friday, April 24, 2020

We’re in this together: How they are delivering unmatched acceleration of COVID-19 diagnostic and therapeutic applications Accelerating much needed COVID-19 testing, vaccines and treatment options across the world can’t be done alone. We’re in this together and ready to apply our unique combination of solutions that blend Covance and Labcorp’s …

Are you ready? Impact of upcoming regulatory requirements on combination product reporting

by Lisa Mooreupdated on Monday, June 7, 2021Thursday, March 19, 2020

Combination Products: What are they? Any product formed from the combination of a drug, a device and a biologic is referred to as a combination product. Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as …