The Medical Device Industry is undergoing a rapid change with an increase in the volume of regulations. Regulatory change management is an amalgamation of quality, compliance and risk management. Regulatory change management can be simply defined as the management of changes in regulatory policy or procedure happening in your industry concerning your organization. Currently, Device regulations are increasing at a rapid rate as regulators from various regions are modifying their policies every year, GDPR and EU MDR are two such regulations that medical device organizations have to comply with. Regulatory Change Management is a critical issue in the field of medical devices but if management systems are inadequate then the chance of incompliance rises. Patient safety is held as the prime concern when managing such regulatory changes. Despite these, RIM solutions backed by Reg Intel are offering a modern approach towards regulatory change management to Device Manufacturers.
RISKS IN REGULATORY CHANGE MANAGEMENT
Regulatory change management is always risky as such changes are unknown. The amount and rapidity of regulatory change that the medical device industry is facing has surmounted to new heights. It tends to create immense pressure on organizations in their financial sector thereby posing a threat to brand image. In such situations, chances of incompliance are higher and hence it stretches the process of approval. This hampers patient safety excessively.
What has changed?
Managing regulatory requirements was easier ten years ago than it is today. With the advent of EU MDR and such other regulatory bodies with stringent regulations, complexity has increased besides ensuring patient safety. Meeting these complexities and yet maintaining time acts as the driving force behind the adoption of Regulatory Intelligence to
Regulatory Information Management (RIM) system.
ROLES AND RESPONSIBILITIES IN CLASSIFYING REGULATORY CHANGE MANAGEMENT
- Primary identification of a regulatory change takes place outside the knowledge of change management team.
- Reviewing this identified regulatory event is necessary to determine its applicability and impact that it might have.
- The role of the review is to monitor areas that have been affected and recognize executives who will be accountable for change management. To implement actual regulatory change
management plan, a broad impact assessment along with planning and gap analysis is necessary.
- It is only through cross-border and cross-functional synchronization can this plan be implemented successfully.
- Validation takes place once the process is finished and involves independent assurance screening as well as steps to relocate program configurations to a business-as-usual form.
- Validation even includes current policies, procedure management and maintenance of the plan. Within these stages, documentation, and coordination of roles and responsibilities
turns to be a critical factor in making any regulatory change management plan successful.
10 BEST WAYS TO MAKE CHANGE MANAGEMENT A PART OF YOUR BUSINESS:
1. Establish effective regulatory oversight systems to help identify and resolve changes promptly by the relevant parties.
2. Establish clear procedures to track data and ownership handoffs, with a detailed audit trail.
3. Create a well-articulated process of cross-functional and cross-product coordination with active involvement from all major business and functional areas.
4. Using modular tools and processes throughout the enterprise that can be phased in.
5. Dedicated Regulatory change management tools with appropriate skills, encouraged by senior management to assist in supporting areas of regulation, legal and market.
6. Define roles and obligations for improving employee engagement and reduce needless effort duplication.
7. Build systems of governance with strong representation and senior leadership’s participation.
8. Using interactive technology to support this unified process of regulatory change and inform the stakeholders on time.
9. Provide auditable complementary documentation added with archiving.
10. Continuous review to make these programs sustain the future regulatory changes.
IS THERE A BETTER APPROACH OR SOLUTION TO REGULATORY CHANGE MANAGEMENT?
“Regulatory Intelligence equipped Regulatory Information Management is the solution”
ViSU offers a solution for Medical Device organizations, allowing them to manage overwhelming level of regulations coming at them from all corners of the globe. This web-based, Reg Intel enabled SaaS RIM platform provides:
Comprehensive and continuous regulatory updates
Acts as an automatic process for data collection and analysis of regulatory policies, notices, whitepapers, executive orders, news and so on.
Content summarization and classification
Classifies extensive regulatory documents and makes a list of all those that are obligatory.
Collaboration and assignment of task
Automatic assignment of role according to task through analysis of risks and collaboration.
Reports with insights for real-time action
Actionable insights are revealed on personalized dashboards making it clear how many regulatory changes might be necessary for a particular business.
Maximized competence & Complete Compliance
Higher chances of approval of marketed applications.
ViSU’s Reg Intel built-in Tech’ is the one that determines which regulatory changes are relevant to the business and particularly in which area. It is based on machine learning (ML) and continually learns via AI to provide a real-time and modern approach to regulatory change management.