Medical Device Risk Management is becoming increasingly critical and complex in today’s medical device and healthcare systems. Many decisions by your organization or regulatory authorities (e.g. FDA) are made based on risks. Your role in risk management is so important, and your job in risk management is more challenging than ever.

 

A comprehensive risk analysis involves multiple tools (Hazard Analysis, Fault Tree Analysis, FMEAs etc.). This has made it difficult to electronically connect all the output cohesively and maintain it all together, reusable (e.g. keeping FTA in its original formats) and in sync through the product life cycle. 

Risk management information is spread across multiple components, devices, sub-systems, documents, or work sheets. This has made it difficult to connect safety critical information systemically and be able to assemble risk reports for an individual product, a family of products, or a system of systems to meet business or compliance needs.

Risk management is a product life cycle process, and involves various functions and disciplines at different stages of a product life i.e. pre-production, production and post-production. This has made it difficult to ensure risk management's consistency and continuity through a product life.

Emerging needs to incorporate broad risks (security , performance etc.) into the Quality System per FDA and international standards (e.g. ISO 13485:2016) are adding another level of challenges. 

Increased complexity of today's medical devices and/or its environments contributes to rising number of product recalls. This has been leading into increased level of regulatory scrutiny (e.g. FDA's requirement for safety assurance cases) for new product approval/clearance or regulatory inspections/audits.

 

These difficulties have constrained organization's capability to establish a risk management program that can effectively ensure compliance, safety, security, connectivity, consistency and productivity. These are the exact reasons why we have designed the TurboAC™ software solutions.

 

Sign up a free trial and find out how exactly our software can help you to overcome these challenges. We are looking forward to hearing from you.

 

 

Thanks and warm regards,

GessNet Leadership Team

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