of regulatory professionals require at least a week to gather the information needed to determine where their products are sold and/or registered*
* Based on a survey of 100 companies
What are the Risks?
It is Illegal
Company fines and product seizures
Lost revenue and import detentions
Ignorance isn’t a defense to culpability
Your Career is at Stake
Regulatory professionals must uphold an ethical code of conduct
It’s your duty to abide by the regulations
Don’t be caught between your company and the law
You Will be Audited
Corrective and Preventive Actions (CAPAs)
Potential loss of company certifications
How RIMSYS Helps.
Maintain Regulatory Information
Medical device classifications and other regulatory information vary by country and product. If you can’t easily find this information in your current system, how efficient can you be getting products to market?
Eliminate the manual administrative functions, the disjointed processes, the outlook task reminders and the color-coded excel files.
Track and Collaborate
Keep detailed notes on communications, upload documents, and track important dates and registration data for your notified body, service providers (e.g. electrical safety certificate), country sponsors, distributors, and more.
A Simple and Intuitive Process to Global Product Registrations
Create a Product Profile
Define product families and business units, and assign products, part numbers, UDI’s and other relevant information about your products.
Link Your Product to a Country
With two (2) simple clicks, you can start the registration process with your product profile and 140+ countries throughout the world.
Collaborate and Start Tracking
Collaborate with distributors or other personnel associated with the registration process by granting access to your registrations. Add detailed notes and communications with regulatory bodies, upload and track documents required for registrations, define device classification information, and assign tasks to your team.
Mapping and Reporting
Click on any country and see exactly where your products are sold and their current registration status. Robust reporting with geospatial mapping gives you, your colleagues, distributors and your management team a bird’s eye view of your products regulatory landscape.
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