Guidance on HIPAA Compliance for Medical Devices

Defining HIPAA Compliance as it pertains to your Medical Device Company.
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Crucial Do’s and Don’ts of SaMD Development

Explore the unique challenges and considerations of SaMD development.
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Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device Development
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The Ultimate SaMD Development Plan

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan
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4 Ways AAMI TIR45 Proves Beneficial for SaMD Development

Easy Guidance for SaMD Development and Agile Practices
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A Regulatory Approach Manual for Device Software Functions

Understanding the policies for your Medical Device Software Functions
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A Quick & Easy Guide to FDA Pre-Submissions

A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!
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Top 20 Medical Device Conferences to Attend in 2020

A simple breakdown of 20 conferences you don't want to miss this year.
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Why Digital Health is Leading the Healthcare Space

Everything you need to know about digital health and its impact, opportunities, and challenges in the life science industry.
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Medical Device Single Audit Program (MDSAP) Explained

A simple breakdown of MDSAP, how it can benefit your company, and detailed instructions on how to get started.
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