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Description

Retail and trade companies are facing increasing scrutiny from customers, investors, NGOs, and regulatory bodies concerning product-related issues. Every day, there are concerns regarding product safety, the presence of banned substances, and energy consumption that fails to meet established standards. The landscape of regulations is growing ever more intricate, and as new technologies are introduced, products themselves are becoming more complicated. Failure to manage these challenges effectively may stifle growth and negatively impact financial outcomes. Therefore, it is essential for management to take control of these critical business aspects. ProductIP offers a Compliance Tracking System (CTS) designed to address these needs. By transforming complex regulatory data into an accessible, step-by-step process that begins with the product itself, companies can gain clarity. This approach enables businesses to ask the right questions of their suppliers and ensures that necessary documents are uploaded in an organized manner, rather than being exchanged haphazardly through emails. With such tools, companies can enhance compliance and streamline their operations.

Description

Emergo by UL's Regulatory Affairs Management Suite (RAMS) is an all-encompassing software-as-a-service solution crafted to optimize regulatory and quality management processes for companies involved in medical devices and in vitro diagnostics. Drawing on extensive expertise in regulatory compliance, RAMS equips users with a range of tools to effectively navigate the intricate and ever-changing realm of global medical device regulations. Among its standout features is product classification, which assists users by guiding them through a structured series of inquiries to ascertain or confirm the classification of their devices. Additionally, the Smart Builder offers comprehensive step-by-step instructions and ready-made text to aid in the creation of precise regulatory documentation, thereby facilitating a smoother path to device registration and expedited market entry. Furthermore, the Registration Tracker serves to automate the oversight of international registrations and certifications, ensuring that organizations do not overlook renewals and consistently uphold compliance standards. This proactive approach not only enhances efficiency but also significantly reduces the risk of regulatory setbacks.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

ProductIP

Founded

2008

Country

Netherlands

Website

www.productip.com

Vendor Details

Company Name

Emergo by UL

Country

United States

Website

www.emergobyul.com/software/regulatory-affairs-management-suite

Product Features

Product Features

Alternatives

Alternatives

MedAffairs AI Reviews

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)