Whitepaper

Regulatory Information Management (RIM) refers to the systems and processes used to manage regulatory data and documents across the product lifecycle. RIM is a common concept for pharmaceutical companies. However the notion of RIM is less prevalent in the Diagnostic space. Although RIM may be a new term for many manufacturers, there are key requirements that make good RIM critical for Diagnostic companies to remain in compliance and achieve greater operational efficiency.

Topics covered in this comprehensive White paper include:

• Medical Device Single Audit Program (MDSAP)
• Control of Product Release and Shipment
• Regulatory Assessment of Product Changes
• Data to Build Regulatory Strategies
• Planning of Regulatory Resources