eMDRs: Fix Your SOPs Now
It’s never too late to work towards compliance, and quick.
Tag Archives: compliance
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…
What Manufacturers Should Know About Reimbursement and Case Management Hotlines for Providers
While support services are important, manufacturers must be aware of both state and Federal regulations, as there can be conflicts and differences in interpretations.
While support services are important, manufacturers must be aware of both state and Federal regulations, as there can be conflicts and differences in interpretations.
What About the Reports?
If you work in the device industry in the United States and introduce FDA approved/cleared product into commerce in the United States, then it is incumbent upon the device establishment to play by FDA’s rules. Remember, if you are playing in FDA’s sandbox, then you must play by FDA’s rules.
Receiving Inspection – Not Much Value; However…
Facilitating a RI department can quickly become an expensive proposition. Adding a vision system, mechanical inspection tools, a reasonably-sized surface plate, and hiring/training competent mechanical inspectors is not cheap. However, device establishments can mitigate some of the costs by implementing some pretty basic inspection concepts.
Health Canada: CMDR Compliance Required for Single-Use Reprocessed Devices
Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to comply with Canadian Medical Device Regulations (CMDR) by September 1, 2015.
Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to comply with Canadian Medical Device Regulations (CMDR) by September 1, 2015.
