Life Science Business Mangement

February 12, 2015
By Rita King
FDA 21 CFR Part 820, FDA Compliance, Quality Management

21 CFR Part 820 Ensures Your Device is Safe and Effective

An Early Practical Handle on 21 CFR Part 820 Improves Your Medical Device Business Operations The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as Quality System Regulation 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective. What...

How to Structure a Medical Device Company

January 28, 2015
By Rita King
FDA Compliance, Medical Devices, Quality Management, Risk Management

How to Structure a New Medical Device Business

There’s More to Being a Medical Device Business than IP and R&D An emerging medical device business tends to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation....

August 9, 2012
By Rita King
FDA Compliance, Quality Management, Risk Management

Life Science Cloud Vendor Selection Part 2

Cloud Vendor Selection for Life Science Companies

July 30, 2012
By Rita King
FDA 21 CFR Part 11, Life Science Software

Cloud Vendor Selection for Life Sciences

Benefits and Risks of Moving to the Cloud, Including Cloud Vendor Selection Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services)...

Tag: Life Science Business Mangement

21 CFR Part 820 Ensures Your Device is Safe and Effective

How to Structure a New Medical Device Business

Life Science Cloud Vendor Selection Part 2

Cloud Vendor Selection for Life Sciences