An Integrated Risk Management process is a necessity for compliance with FDA and ISO regulations.
We can help you –
Design safety in to prevent safety related problems in the field
Encourage a defect prevention mindset by integrating Risk Management throughout the Product Development Process
Identify potential safety issues, including Use Errors, and effectively address them through design
Create all risk management deliverables to demonstrate adequacy for regulatory body submissions
Allow Risk Based decisions to be made throughout the product lifecycle.
Integrate Risk Management into other Quality Management System processes, such as CAPA, Supplier Management and Complaint Handling
Substantiate due diligence for liability protection
Generation of Safety Assurance Cases