Medical Device CRO

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New! Documentation in Devices

Ensure your documentation proves
that your patients are protected

Monitoring as
a Mindset

Art of Effective Monitoring for a Medical Device Trial

510(k) Download

Conducting a Well-Controlled Clinical Study When Clinical Data is Required

Medical Device CRO Blog

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Should the Medical Device Industry Embrace Outsourcing?

What Exactly Are Device-Drug Combination Products?

Safety > Efficacy?

“21 CFR 50.25(c): New Requirement for Consent Forms Being Enforced”

Will a More Rigorous FDA Equate to Longer 510(k) Clearance?

Top 10 2011 FDA Warning Letter Findings for Clinical Investigators

What is the Value of Social Media for Medical Device Companies?

Do The FDA & Medical Device Industry Finally Agree?

Will 2.3% Sales Tax Push Med-tech Companies Overseas?

Cell Therapy Products… Falling into the HDE Category?

What’s on the FDA's "To Do" List for Devices in 2012?

Should Smaller Med-tech Companies Avoid Emerging Markets?

Shortened Informed Consent Form

Confusion with ‘Chemical Action’

FDA Misses MDUFMA Deadline

Documentation in Device Studies: Proving Patient Protection

Stem Cell Fraud

Ensuring Proper Protections for Vulnerable Research Subjects

Continuity in Medical Device Reviews

Have You Been Asked to Provide Vendor Credentials?

A Monitor’s New Years’ Resolutions

Gender Guidance

Santa & the IRB

The Note-to-File Magic Eraser

Effective Responses to Avoid Warning Letters

Partnering for an Improved Process

FDA Issues Two Draft Guidance Documents

FDA Forming an Expert Panel

Patent Reform Could Help Medical Device Startup Companies

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IMARC RESEARCH, INC.