When Complaint Investigations Meet Servicing and Repairing Devices
Many companies are unsure of how to complete a complaint investigation when the service and repair process is involved.
Tag Archives: compliance
What You Do Beyond Compliance Matters
We all talk about cross-collaboration, but do we really practice it?
One, Two, Three Strikes You’re Out…Or, Receive a Warning Letter
It is in the best interest of an offending establishment to be timely and complete in responding to Form 483 observations.
eMDRs Part Deux: FDA on a Mission
The agency is focused on ensuring device establishments accelerate compliance with the eMDR process.
eMDRs: Fix Your SOPs Now
It’s never too late to work towards compliance, and quick.
Why the Hybrid Cloud is Practical for Medical Device Manufacturers
Cloud-based information management platforms improve collaboration without sacrificing compliance.
Only Two Form 483 Observations Can Equate to a Warning Letter
You must have established procedures for complaint management and MDRs.
No Excuses for Repeat Violations!
Get an instant warning letter with repeat Form 483 observations.
Device Meet Drug: Integrating Combination Products Into Your Portfolio
Combination products are a major growth area for life science companies and in the future, many companies have or will have combination products in their portfolio. Combination products are made of drug, device and/or biologics constituent parts. Each constituent part has its own set of regulations to which it must adhere. For example, even if…
Health Hazard Evaluations: Focus on Complaints and the Patient
When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…
