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?
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.
GDPR: What is it and what does it mean for your clinical studies: Part I
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?
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 …
Labcorp delivers unmatched COVID-19 diagnostic and therapeutic applications
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 …
ISO 14155 update: key risk management changes for medical device clinical investigations in 2019
The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year. According to the International Organization for Standards (ISO), the updated edition will focus on …
How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies
How could a no-deal Brexit affect my medical device lifecycle? Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario. The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical …
Choosing the Best Pathway for CDx Development and Commercialization
Drug developers are increasingly incorporating a CDx development (companion diagnostic) strategy into their programs to deliver safer, more effective and appropriate therapies to the right patients. While the end result can be significantly beneficial for patients, and development partners, the path from analytical and clinical validation to demonstrating clinical utility and obtaining regulatory …