Guidance on HIPAA Compliance for Medical Devices

Defining HIPAA Compliance as it pertains to your Medical Device Company.
Read more

What are CAPAs?

Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
Read more

How to Create Successful SOPs for your Medical Device

Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
Read more

What are Standard Operating Procedures (SOPs)?

Defining SOP’s as they pertain to your Medical Device.
Read more

Crucial Do’s and Don’ts of SaMD Development

Explore the unique challenges and considerations of SaMD development.
Read more

Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device Development
Read more

What is FDA's 21 CFR Part 820?

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
Read more

The Ultimate SaMD Development Plan

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan
Read more

4 Ways AAMI TIR45 Proves Beneficial for SaMD Development

Easy Guidance for SaMD Development and Agile Practices
Read more

A Simple Guide to 510(k) Applications for Medical Devices

Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications
Read more

Recent Posts

Topics

See all

Subscribe Here