Want to learn how to get your medical devices to market faster and with fewer risks? In this article we cover 6 software solutions by RegDesk that address the most common challenges faced by regulatory affairs teams and reveal how most companies are making the medical device submissions process far more complicated than it needs to be.
In today’s globalized world, medical device manufacturers are able to reach more markets than ever, but with more markets comes more regulatory challenges. Besides the challenge of processing submissions for more markets, regulatory affairs teams are also faces with increasingly stringent medical device regulation all over the world. In fact, the increased complexity of gaining marketing approval has far outstripped progress made in manufacturing and distributing devices.
In many ways this is a good thing. Stringent regulations help improve the safety and effectiveness of medical devices on the market, they also help even the playing field among manufacturers by discouraging certain players from rushing products to markets. This is particularly true in emerging markets that until recently had little regulatory oversight.
The Challenge
Unfortunately, the heterogeneous nature of today’s international medical device regulations has made the approval process dauting to even the most established and experienced manufacturers. The challenge is rooted in data acquisition and management. Traditional methods of compiling regulatory requirements and managing communications between regulatory affairs teams and international partners are being overwhelmed by the volume of data required for medical device submissions these days. Recently, a new software category has recently emerged to address this problem. Regulatory Information Management Systems (RIMS) are designed to store and manage regulatory data. These platforms make it easier to share and update regulatory data and often incorporate regulatory intelligence and submissions templates. However, few utilize the full potential of modern software technology. Some advertise AI software, but that usually amounts to matching products to applicable regional templates.
RegDesk Dash™ is much more than that. Our platform was developed in response to the lethargic pace of innovation prevalent among RIMS. It is not a mere repository of information; it is a digital toolbox filled with cutting-edge applications that handle the most time-consuming and tedious regulatory tasks for you.
What are these applications? Let’s list them:
1.Regulatory Intelligence
RegDesk Dash™ provides instant access to comprehensive regulatory requirements for more than 115 countries. Requirements are condensed into concise, easy-to-follow steps and translated to English when necessary. Our analysts continuously monitor the global regulatory landscape to ensure our requirements are updated and accurate.
2. Automated Tracking and Alerts
With RegDesk Alerts™, users receive automated alerts to submission renewal deadlines and regulatory changes that affect your products.
3. AI-Powered Application Builder
RegDesks’s innovative application builder consolidates the medical device and pharma submission process into fillable forms. Simply follow the prompts and our AI-powered software automatically generates jurisdiction-specific dossiers based on information provided. Clients have reported that our Application builder reduced the submission building process from months to hours.
4. Change Assessment Generation
Change assessment is made is with RegDesk’s change assessment module, which allows users to understand the impact of the type(s) of changes to their existing products. It also provides an analysis of the products, SKUs, and countries that would be impacted by the change. Change assessment projects across the world can be managed through streamlined workflows.
5. Standards Management
Allows users to search for international and country-specific standards. The standards can be indexed by products and countries. The user can also specify the level of compliance to a standard. Our system can auto-populate Essential Requirements, GSPR, Declaration of Conformity, and Regulatory Strategy plan using A.I.
6. Consulting Network
RegDesk’s Peer™ module provides instant access to a global network of more than 4,000 regulatory consultants. While most companies rely on consultants with limited global knowledge or firms that are often busy with their numerous other clients, RegDesk instantly connects you with multiple consultants possessing the appropriate knowledge and experience to address your problems. Typically, our clients can expect multiple responses to their questions within two weeks. Receiving multiple responses enables users to form a well-rounded view of their problem and potential solutions, maximizing their chances of achieving approval with their first submission.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
