All "Medical Devices" articles

3 Important FDA Medical Device Guidance Documents to Bookmark

Are you struggling with medical device regulatory compliance? If so, you’re not alone. It’s an issue that thousands of growing medical device ...

EU Medical Device Training: 4 Amazing Programs

Today’s most successful organizations commit to continuous learning. It’s what separates industry-leading medical device and pharmaceutical startups ...

Expanding Med Device Distribution Internationally and in China

Subscribe on any major podcast player. Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company ...

4 Major Class II Medical Device Requirements

Many growing startups and scale-ups deal with non-compliance issues at one point or another.  Unfortunately, failure to meet major medical device ...

How to Build the Best Quality Assurance Plan for Distributed Medical Manufacturers

What does it take to deliver maximum quality assurance? The most effective medical device manufacturers commit to quality-driven processes and ...

5 Major CAPA Medical Device Requirements

The corrective and preventive action (CAPA) quality processes consist of the critical activities life sciences organizations must activate to ...

5 FDA Pre-Submission Tips for Medical Device Manufacturers

You've just designed the greatest medical device of all-time. Now what? If you've developed a medical device similar to one that's already available ...

Understanding Risk Classification of Medical Devices: 3 Major Grades

Did you know that classifying your medical device incorrectly could extend the Food and Drug Administration's (FDA) approval process by months? As ...

5 Medical Device Supplier Innovations in 2020

Medical device suppliers have unveiled some amazing innovations this year. Failing to keep tabs on these advancements could keep you from growing ...

The 5 Best Medical Device Product Lifecycle Management Tools

Picking the right medical device product life cycle management (PLM) tool is a huge deal. Selecting the wrong PLM could lead to headaches and legal ...

4 Medical Device Manufacturers Revolutionizing Life Sciences in 2020

This year, medical device manufacturers are rising to the COVID-19 challenge by developing innovative new products. For example, industry leaders ...

5 Essential Elements of a QMS for Medical Devices

Are you planning on investing in a Quality Management System (eQMS) for your medical device company? Without careful consideration and planning, a ...
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