Effective use of a risk management process through product development and through the product life cycle can be a great asset to any organisation. When used effectively, it can provide solid rationales and provide robust justifications for clinical, validation, operational and strategic decisions around testing, vigilance and recall activities to name but a few.
- ISO 14971 compliance is a requirement for most geographies. How do I implement it for my class of device?
- How do I use risk management in the vigilance and recall processes?
- How can I expand the principles of risk management to my other QMS processes?
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›