Rimsys Regulatory Management Software

Rimsys Regulatory Management Software is a solution designed to digitize and automate regulatory activities for medical technology companies. According to the vendor, it caters to businesses of various sizes, from small startups to large multinational corporations, and is utilized by regulatory affairs professionals, quality assurance professionals, compliance officers, medical device manufacturers, and pharmaceutical companies.

Key Features

Centralize all regulatory information: According to the vendor, the software allows users to create a centralized platform to organize and consolidate registrations, certificates, submission documents, technical files, UDI, and correspondence with health authorities. It aims to ensure consistent and up-to-date information for all team members.

Streamline submissions: The vendor states that the software enables collaboration with team members and in-country sponsors using pre-built digital templates to assemble regulatory applications. It is said to utilize intelligent reusable content and automated approval workflows to streamline the submission process and improve efficiency.

Monitor market status: According to the vendor, the software automatically tracks registration and selling status, expirations, relevant standards, and regulatory news to ensure products can stay on the market without disruption. It aims to keep users informed about any changes that may impact market status.

Product registrations: The vendor claims that the software allows users to monitor and manage global product registrations, certificates, and expirations. It aims to help keep track of regulatory requirements and deadlines to ensure compliance with product registration processes.

Submissions: According to the vendor, the software enables collaborative authoring and assembly of regulatory applications, providing access to pre-built government templates for various regulatory agencies. It aims to simplify the submission process and ensure compliance.

Unique device identification: The vendor states that the software helps users manage global UDI information alongside product registrations, auto-generating UDI records for different countries. It is said to integrate UDI data with product registration records for streamlined management.

Regulatory intelligence: According to the vendor, the software allows users to track relevant laws, regulations, guidance, and news to stay up-to-date with the latest regulatory changes. It provides access to curated regulatory newsfeeds within the platform for comprehensive regulatory intelligence.

Essential principles: The vendor claims that the software helps users create and maintain essential principles/general safety and performance requirements (GSPR) tables. It aims to facilitate collaboration with the team to determine applicability and apply standards, with automated approval workflows and notifications for changes.

Standards management: According to the vendor, the software proactively monitors changing global standards, allowing users to build a customizable library of relevant standards. It aims to help link standards to individual products and assess the impact of changes to ensure compliance.

Integrations: The vendor states that the software enables easy integration of clinical, product, and quality information across the organization. It allows users to update market clearance and selling status directly in ERP or CRM systems, aiming to ensure MDSAP compliance through seamless integrations.