Compliance Blog | Topics Shaping Our Industry

, What is Your Biggest Compliance Frustration?

What is Your Biggest Compliance Frustration?

What is your biggest compliance frustration?  This is the question I recently asked on LinkedIn.  I posted it on my own LinkedIn profile and in a number of groups of which I am a...

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, Software Validation Master Plan – Path to Success

Software Validation Master Plan – Path to Success

Software Validation Master Plan Part 2 in our Part 11 Compliance and Validation Blog Series In this post, we will be exploring the 1st Essential Building Block of our Part 11 Compliance and Validation...

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, Part 11 Compliance and Validation

Part 11 Compliance and Validation

Building a Part 11 Compliance and Validation Framework – Part 1 of 8 Do you have the 7 essential building blocks necessary for a successful Part 11 Compliance and Validation framework?   If you...

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, Where Should I Market My Medical Device First?

Where Should I Market My Medical Device First?

“Where should I market my medical device first?” is a question I encounter on a regular basis with my early stage and start-up clients. The answer is not as direct as you might think...

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, 5 Tips to Conduct Effective Medical Device Quality Audits

5 Tips to Conduct Effective Medical Device Quality Audits

Do you struggle staying within the scope of your audit?  Are you often overwhelmed by the volume of material to review during the course of an audit?  Here are 5 tips that help me...

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, 5 Steps for Bulletproof Supplier Controls

5 Steps for Bulletproof Supplier Controls

Who’s in the driver’s seat of your medical device supply chain?  You?  Or the FDA? Right now, industry executives are bending over backwards to meet strict regulatory, safety, and quality system requirements, to navigate ever-changing submissions processes and...

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, 3 Tips for Creating FDA Compliant Training Programs

3 Tips for Creating FDA Compliant Training Programs

Tip 1: Create Job Descriptions You might be asking yourself… “What do job descriptions have to do with creating effective FDA Compliant training programs?” The answer is EVERYTHING. When you create comprehensive job descriptions,...

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