Executive Summary

The medical device, in vitro diagnostics, and pharmaceutical industries are facing increasing challenges in managing the complexities of a fragmented and evolving regulatory landscape. Regulatory affairs professionals struggle with fragmented information sources, frequent regulatory updates, and resource constraints, making it difficult to maintain compliance and ensure timely product oversight. These issues can lead to costly delays and increased risk of non-compliance, especially as the regulatory environment lacks harmonization and coordination across global markets.

MedBoard addresses these challenges with a centralized platform that integrates regulatory intelligence, workflow automation, and artificial intelligence to streamline compliance tasks. Key features include real-time regulatory updates, advanced search capabilities, a compliance manager dashboard, and a regulatory information management system (RIMS). By automating routine tasks and providing proactive insights, MedBoard helps regulatory teams save time, reduce risk, and focus on strategic initiatives. This comprehensive solution delivers long-term value, ensuring businesses can navigate regulatory complexities while supporting innovation and minimizing compliance risks.

1 Current Landscape of Regulatory Compliance

1.1 Introduction

The medical devices, in vitro diagnostics and the pharmaceutical industry are facing increasing challenges in keeping up with the applicable regulatory environment. Companies and especially regulatory affairs professionals must navigate an ever-changing regulatory landscape in a fragmented world lacking clarity, harmonization and coordination, despite best efforts from regulators.

The increasing complexity is creating a high risk of non-compliance and regulatory affairs are struggling to maintain a balance between ensuring that projects are executed timely, spending enough time to perform regulatory intelligence and spreading knowledge and maintain marketed products in compliance.

The lack of coordination between standardization organization and regulators/compliance bodies is adding an additional layer of complexity for manufacturers as current and future expectations and acknowledge state-of-the-art are unclear and can change at any time. Development costs and timeline can be heavily impacted if there is a sudden change in expected compliance triggering additional testing or redesign.

1.2 Issues and Challenges in Regulatory Intelligence

Managers and members of regulatory affairs departments are facing many challenges:

a. Fragmented Information Sources

Most regulatory teams rely on disparate sources such as spreadsheets with links, manual web searches, email alerts, and agency/specialized website review, … Managers are facing challenges in task allocation as this manual approach is both time-consuming and dull. This process is also generating a lot of distraction for the team members due to multiple and duplicate e-mail alerts and internal e-mail forwarded by colleagues and other departments. Outcomes are dependent on the person(s) assigned to the task and prone to information gap.

b. Keeping Up with Frequent Updates

Due to the volume of the continuous stream of new requirements, especially in companies addressing the global market, tracking of current and future regulatory landscape is a challenge for regulatory teams. Small to mid-sized teams often, due to time constraints, do not properly disseminate the changes in regulatory landscape among the team members and within the organization, making it difficult to achieve a proactive compliance strategy.

c. Impact Assessment and Implementation

Change assessments, which often require subject matter experts from other departments, are sometimes not detailed enough, delayed or simply not performed in a timely manner. The high number of changes open simultaneously at a given time is making it difficult for managers to have an overview and to prioritize resources allocation, often leading to sub-optimum and last-minute implementation. For the same reason, regulatory experts are also struggling to make a pragmatic and holistic implementation instead of sequential updates.

d. Product Maintenance and Update

Being able to maintain a clear overview of which product is impacted by a particular standard update is crucial. For small companies without a dedicated team for product maintenance, ensuring products’ technical documentation is updated timely, in all jurisdictions is a strenuous for the regulatory affairs team.

e. Regulatory approval oversight

Keeping an overview of which device or variant is approved/cleared in which region can quickly become a challenge for regulatory affairs teams. Often knowledge is held by specific individuals who have been working in the same department for a long time and records are buried somewhere in the basement. Failure to maintain overview and timely access to records can lead to recalls, violations, and significant financial and reputational harm.

2. MedBoard: The solution to streamline compliance & resources

MedBoard is more than a simple regulatory intelligence platform, it is an ecosystem of solutions enabling marketing, R&D, clinical, and regulatory affairs professionals to perform better, smarter and faster. MedBoard is specifically targeting the needs of people involved in the development, compliance, and commercialization of medical devices, in-vitro diagnostics and pharmaceuticals. By centralizing market, clinical, and regulatory information and adding workflow. Automation, and artificial intelligence features, MedBoard provides robust data management tools, addressing the industry’s core compliance challenges.

2.1 Key Features of MedBoard

a) Centralized Access to Trusted Information

MedBoard aggregates regulatory updates from numerous regulatory agencies, standardization organizations, scientific repository, and trusted regulatory news websites. New information are continuously added to MedBoard dataset. Never missed an update, thanks to customizable alerts and notifications.

b) Advanced Search Capabilities

MedBoard allows to browse information by category (country, topic, agency, …) or based on pre-defined search criteria. Information can also be consulted through reports, automated collection, and news feeds. Elastic search using Boolean operators can be used to find information throughout the entire database.

c) Compliance Manager

The compliance manager’s dashboard provides an overview of the compliance status of the company regarding applicable regulatory documents, quality management system (QMS) procedures and technical documentation (TD) in real time. A task manager is allowing the assignment of activities to regulatory contributors, linking trigger (regulatory document) and target (QMS/TD), and following the task status based on due date.

d) Regulatory Information Management System (RIMS)

MedBoard’s regulatory information management system allows to visualize your entire product portfolio and the current registration status at a glance. The product information and country registration module cover all functionalities available in the major RIMS solutions, but it is fully integrated with the regulatory intelligence and the compliance manager functionality, allowing to seamlessly process an item from its publication to a marketed product.

e) Clinical Repository (Literature, Study, Clinical Guideline)

MedBoard’s systematic review (SR) function is removing the need to run queries in multiple websites (PubMed, Google Scholar, …). Articles are automatically imported from external sources and appraisal can be done without using separate excel spreadsheets. Prisma assessments, analytics, and references management are embedded in the platform, removing the need to manually generate information.