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Every other month, you will receive information about important regulatory, clinical, and quality assurance issues and requirements that affect the medical device industry.

We'll discuss best practices and current industry trends to help you better manage your business and ensure your product's regulatory compliance.

Browse the archive below and click here to start your subscription or update an existing subscription. You may unsubscribe at any time and your privacy is always assured.

Newsletter Archive

Mar 2006

What You Don't Know CAN Hurt You. FDA's New Approach to Postmarket Device Safety

Oct 2005

FDA FY2006 User Fee rates and payment procedures and Waste not, want not...New Rules for EU that may change medical device design.

Jul 2005

Positive and Negative Effects of MDUFMA User Fee Legislation.

Apr 2005

Consensus Summit on Regulatory Issues Involving Combination Products & Recent Changes in Personnel at ODE.

Feb 2005

Labeling for In Vitro Diagnostic Devices - Use of Symbols

Nov 2004

Medical Device Outsourcing and Quality Compliance: Who is Responsible?

Sep 2004

BIMO Audits - Do You Know What Can Raise FDA Suspicion?

Jul 2004

Selecting an EU Authorized Representative: Are You Asking These Important Questions?

May 2004

Risk Management for Medical Devices - ISO 14971: What Does it Mean for Your Product?

Mar 2004

Understanding the FDA Request for Designation (RFD) Process

Jan 2004

Important Information About FDA's Third Party Inspection Program

Nov 2003

Do You Qualify for Reduced Medical Device User Fees?

Jul 2003

Are You Prepared for the Dec. 2003 IVDD Deadline?

Apr 2003

MDUFMA Update: Medical Device User Fee Payment Procedures

Jan 2003

MDUFMA Labeling Requirement Could Have Significant Impact on Medical Device Design

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