April 25, 2024
Case Study: Mastering Manufacturing Compliance
About The Client Compliance Team worked with a manufacturer of [...]
Author: Michelle Bonn
Michelle leads Compliance Team's strategic direction and vision. She ensures the team is executing on corporate sales, operational improvements, and expanding service offerings.
October 12, 2023
Life Science Mergers & Acquisitions – Performing Effective Due Diligence
When companies are acquired or merge, inherent risk is [...]
September 26, 2023
What Are The Requirements For A Cyber Device In The Medical Industry?
In a previous article, I explained that cybersecurity attacks in [...]
September 23, 2022
Data Integrity in a New QMS
Data Integrity isn’t just a buzzword; it is a way of life. As [...]
September 8, 2022
How to Apply Statistical Techniques in a Quality Management System (QMS)
21 CFR 820, Subpart O, the last subpart of the Quality System [...]
August 24, 2022
What Is A Drug Master File (DMF)?
What Is A Drug Master File (DMF)? A Drug Master File (DMF) is a [...]
August 3, 2022
Understanding Clinical Evidence and Risks During Expedited Approval
Expedited approval is a business necessity for companies, [...]
July 20, 2022
How to Know if Your Product is a Medical Device
Want to know if your medical product is a medical device in the [...]
July 19, 2022
What are the regulatory guidelines for cannabis manufacturers?
In the United States, cannabis is regulated by the states that [...]