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

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_V1

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

This two-part blog serves to summarize Covance 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 Covance Medical Device and Diagnostic Solutions through a review of the …

GDPR_V1

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

This two-part blog serves to summarize Covance 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 Covance Medical Device and Diagnostic Solutions through a review of the …

covid-19 covance labcorp diagnostics drug development

Covance and LabCorp Deliver Unmatched COVID-19 Diagnostic and Therapeutic Applications

We’re in this together: How Covance and LabCorp 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 …

Futuristic Hexagons

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 …

Image of Flag of Great Britain Overlapped with United Nations Flag

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 …

Image of Hand Pressing Futuristic Tablet

Impact to the Bioanalytical Community of the FDA Issuance of the Draft Guidance on Biomarker Qualification: Evidentiary Framework

The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers.  It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs.  As such, this Draft Guidance supports the Qualification of Drug Development Tools …

Empowering CRAs with Mobile Technology to Improve Site Quality through Monitoring Efficiency

Clinical research associates (CRAs) need immediate access to relevant and accurate site performance metrics, but information is often isolated within multiple databases and spread across different tracking systems. To deliver key site performance data to CRAs via mobile and web applications – quickly and conveniently – Covance has created a …