An Overwhelming Compliance Problem
- Agencies around the world require medical device makers to establish complaint-handling procedures to document, evaluate, and appropriately address product-related problems. The most severe cases require Medical Device Reports (MDRs) to be submitted according to strict timelines that often vary by country. The practical challenges of establishing and maintaining a complaint-handling system are overwhelming given the complexities of country-level regulation, multiple product lines, multiple manufacturing sites, and a constantly changing regulatory environment.
- In 2012, complaint management violations were the top cause of FDA warning letters. Our analysis shows a 30% increase in the number of complaint handling violations from the previous year.
- Our client surveys indicate that the cost of complaint handling systems is extraordinary, and yet the cost of neglecting them is far higher.
- Every year medical device companies are caught with inadequate complaint handling systems and subjected to seizure, fines, prosecution and lost market share, resulting in catastrophic consequences to device makers.
An Innovative Solution
- Argos Global focuses on providing comprehensive complaint-handling services at globally competitive rates exclusively for the medical device industry.
- Our innovative functional outsourcing services provide medical device firms relief from routine complaint reporting. By using our proprietary system, we enable maximum efficiency and ensure regulatory compliance so your team can focus on developing the best medical devices available.
- Typical client results include a 35% reduction in complaint-handling costs while achieving increased levels of regulatory compliance. We guarantee 99% compliance to regulatory reporting timelines.
- We are able to provide in-depth training for all responsible parties in your complaint handling system to help improve complaint handling efficiency.
- Our team of experts are experienced with remediation and backlog reduction projects as well as upgrading paper-based systems to fully compliant electronic systems.
- Our extensive complaint handling knowledge and flexible software allows quickly growing firms to seamlessly enter new geographies fully compliant.
- Our teams of experts have extensive complaint handling and reporting expertise in many geographies, including the US, Europe, Israel, Japan, Taiwan, Brazil, Australia, New Zealand and Canada.
- With the ability to provide industry leading service with state-of-the-art software at globally competitive pricing, Argos Global offers turn-key compliance for truly unmatchable value.
Why Choose Argos Global as your Outsourcing Partner?