Complaints Handling Posts

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Complaints can come from anywhere; it’s what you do with them that matters.

And when it comes to reportable events, time is what matters most. The clock begins ticking the moment your organization becomes aware of a complaint. Having an easy-to-use, intuitive medical device complaint handling system can make all the difference when you need to quickly get information to the FDA CDRH or any other regulatory body. Your organization may never be able to fully eliminate complaints, but it can improve their handling.


Product Liability: How Exposed Are You?

Mark Crawford

According to regulatory compliance expert James Kolka, management too often ignores the legal and financial threats posed by product liability lawsuits.

“Management often believes that compliance with FDA’s Quality System Regulation (QSR) protects the company from product liability exposure,” says Kolka. “Consequently, the task of product liability management is invisible and not audited. It seems to materialize when there is a lawsuit and a mad scramble to find who is or should have been responsible.” (more…)

Compliance is Nothing More than Risk in Sheep’s Clothing

Regulatory requirements around the world have grown, creating heavy workloads of documentation and the need for process transparency.  In addition to rising compliance concerns, Life Sciences organizations face increased security measures, including HIPAA, FDAA 2007 and more.

Regulatory risk is the possibility of being out of compliance. For many Life Sciences companies, regulations rule your compliance objectives. How you handle it is based on your product, production processes and your level of tolerance for risk. A high tolerance for risk might equate to lower compliance costs, but potentially higher non-compliance penalties.