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Medical Device CRO Blog

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New Regulatory Reform

510(k) Guidelines: Can Everyone Win? Or Does Everyone Lose?

Six Money Saving Strategies for Medical Device Companies

The Top 5 Complications of FDA Medical Device Trials

Are Clinical Trials Providing Too Little Information?

Five Points to Consider When Choosing a CRO

Screening or Consent: Which Came First?

Monitoring: A Risked-Based Approach Day-to-Day

FDA Required to Write Rudimentary Regulations?

Is Health and Wellness Focus Hurting Medical Device Firms?

What is a Device You Use at Least Twice a Day?

FDA’s Disqualification of a Clinical Investigator

Is the FDA Pointing the Finger at EU’s Device Review?

A LinkedIn Group’s Repeal Appeal

New Audit Form for Medical Device Regulators

Top 5: Industry Acronyms

Who is Better Organized: The FDA or EMA?

Four Goals for Improving FDA’s Global Reach

FDA & 510(k): Could a 30-Day Review be a Reality?

Building Successful Preclinical Communications Strategies

The FDA’s Pathway to Innovation

Significant Risk/Non-Significant Risk Determination Whitepaper

The Jobs Act: Good or Bad for Healthcare Startups?

Six Mistakes to Avoid When Launching Medical Devices in Europe

Outside U.S. Clinical Trial Data

How Does the FDA Make Benefit-Risk Determinations?

21 CFR 812.20: Was Enough Information Provided to the FDA?

Do You Agree? Is the 510(k) a Pathway to Peril?

Finding the Hidden Costs in the Medical Device Tax

The Ensuring Safe Medical Devices for Patients Act

What Concerns Medical Device Professionals?

Moving Forward: The Medical Device User Fee Act

Clinical Data Requirements for 510(k) Studies

Continued Review of Clinical Trials – IRB Oversight

New FDA Guidance: How Best to Disclose Conflict of Interest

Is the FDA Moving In the Right Direction?

Is It Time For the FDA to Consider Regulation Renovation?

Should Medical Device Companies Use Key Opinion Leaders?

FDA Approving Devices on Both Safety and Effectiveness

Should the FDA Modify the De Novo Process?

Should the FDA Require Standardizing Data Submissions?

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