Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat diseases. Strict rules ensure patient safety and treatment efficacy. However, compliance is notoriously tricky for medical device companies.
Regulatory information management systems give business more insight and control over complex laws and standards. These solutions can streamline compliance, helping your business enjoy faster approval processes and higher overall growth.
Table of Contents
Medical Device Regulatory Compliance Challenges
Let’s explore some typical obstacles associated with meeting applicable standards.
Rapidly Changing Medical Device Regulations
Many medical technology companies struggle to adapt to the constantly evolving regulations. Staying current with the latest standards and maintaining the resources to make changes quickly is particularly challenging for global companies.
Regulation Complexity
Another challenge for medical device companies is understanding different countries’ and regions’ complex and varying regulations. These standards are precise and definitive to ensure patient safety and device performance. The lack of standardization across different authorities can be incredibly confusing, making it increasingly onerous for businesses to keep track of unique regulations and ensure compliance with each applicable rule.
Global Market Access
With so many diverse rules and regulations for medical devices globally, expanding into new markets can be another significant roadblock for the medical technology industry. For example, businesses must align with the European Medicines Agency, the U.S. Food & Drug Administration and Health Canada.
Adequate and efficient supply chain management is another everyday struggle for medical device companies regarding global market access.
Cybersecurity Concerns
Cybercrime is rapidly advancing and becoming a thornier problem within the global health care industry. Medical device companies must prioritize robust cybersecurity practices to combat cybercriminals looking to steal sensitive health information.
Businesses must comply with medical device regulations, guidance and standards specifically for securing and protecting data.
How a RIMS Platform Can Help You Comply With Medical Device Regulations
A regulatory information management system is software designed to streamline how businesses manage and track compliance data and documentation. These applications typically feature advanced tools for monitoring various regulations, identifying new updates and creating detailed reports.
RegDesk’s Regulatory Information Management System uses AI to streamline how you prepare and manage submissions with the most up-to-date regulatory intelligence tools on the market. What are the benefits of leveraging a RIMS platform like ours for medical device compliance?
Centralized Regulatory Data
RIMS solutions provide one central platform for managing all your medical device business’ regulatory data, including:
- Regulatory requirements
- Submission documents
- Compliance records
Having access to a centralized repository enables medical device companies to improve overall data accessibility and convenience while ultimately streamlining regulatory processes.
Improved Compliance
Using a RIMS platform also helps medical technology companies remain compliant despite ever-evolving regulations. This software provides advanced tools for tracking regulatory changes, managing submissions and maintaining documentation according to the latest requirements mandated by medical device authorities worldwide. A RIMS solution can help companies avoid rejected submissions and violations.
Enhanced Efficiency
Another advantage of a RIMS platform is access to automated tools that streamline many essential regulatory compliance tasks, such as:
- Document management
- Submission tracking
- Reporting
A RIMS solution supercharges efficiency by reducing the time and energy required for these tasks while reducing manual errors that can slow or halt the approval process. Enhanced efficiency ultimately means faster time-to-market for new medical devices.
Boosted Risk Management
A RIMS platform can increase speed and accuracy of identifying risks for medical device businesses. The sooner your company can flag an issue with regulatory compliance, the faster you can mitigate the problem and get on track for approval.
RIMS solutions enable companies to proactively approach compliance, effectively combating potential problems before they arise.
Detailed Audit Trails and Documentation
RIMS platforms also ensure traceability and accountability of regulatory activities by providing detailed and accurate audit trails. Medical device companies can use this software to facilitate streamlined audits and inspections, demonstrating compliance to regulatory authorities and agencies.
Considerations for Investing in RIMS Software
Consider the following four factors when selecting RIMS software for your medical device business.
1. User-Friendly Interface
Prioritize user-friendliness when choosing a RIMS. Your team needs a simple, frustration-free way to handle regulatory compliance standards and documentation. A system with a minimal learning curve will help your medical device company maintain accuracy, productivity and efficiency.
2. Advanced Technologies
When picking a RIMS platform for your business, look for technologies and capabilities that will benefit your bottom line, such as AI and predictive analytics.
Artificial intelligence can streamline repetitive tasks like document classification and data extraction, saving your team valuable time and energy. Predictive analytics powered by AI optimize decision-making by anticipating regulatory changes and actively identifying compliance risks.
3. Real-Time Data and Analytics
Choose a RIMS platform that can offer real-time insight into changing regulatory activities. The most advanced software can share notifications and alerts with your business as compliance standards change, enabling your team to stay abreast of all relevant regulatory needs.
4. Integration With External Systems
Another factor to consider when selecting a regulatory information management system for your company is how the software integrates with your external systems. Proper integration enables:
- Fewer data silos
- Improved consistency across systems
- Efficient data exchanges
RegDesk’s RIMS Software for Medical Technology
RegDesk’s RIMS platform has advanced AI technology and impressive features to empower medical device businesses. Our software will reduce the time and effort required to get your company’s latest products to global markets by ensuring compliance with the latest regulatory standards.
We’ll help your business stay ahead of the curve and thrive, despite the many challenges of getting compliant medical devices into the hands of health care professionals worldwide.
Request a Demo of the Regulatory Intelligence Software from RegDesk
Streamline medical device compliance with RegDesk’s holistic RIMS software. Our one-of-a-kind platform features AI-powered automation and real-time regulatory requirements for over 120 markets worldwide.
RegDesk continuously monitors legislation, standards and guidance documents to provide daily alerts regarding evolving medical device regulations. Our software makes life cycle management easier than ever with a single, centralized platform. The distributor collaboration tool and AI-enabled submission generator enable effortless global submission preparation for your operation.
Are you interested in learning more? Request a demo of our cutting-edge solution today.
