SERVICES
REGULATORY INTELLIGENCE RISĒ is actively engaged with global regulatory agencies and notified bodies to identify potential changes affecting your medical device and provides facts for decision making. (DISCLAIMER: Product Coming Soon) RISĒ uses propeitary Risk & Quality Management System (RQMS) using Artificial Intelligence to identify changes affecting medical device regulatory compliance in Real-Time using Real-World Evidence (RWE). | REGULATORY STRATEGY RISĒ understands your product and global regulatory landascapes to provide solutions for product marketization, effectively. We offer country specific strategies or global market strategies for upto 5 years with project specific gantt charts for your team. |
| REGULATORY SUBMISSIONS RISĒ employees are experienced, ethical, remarkable, and aim for your regulatory success. Our expertise is unmateched in high-risk, implantable medical device submissions with accuracy and complete applications (510k, PMA, De Novo, Emergency Use Access, & Breakthrough designation) within effective time-line for your success. | RECALL MANAGEMENT RISĒ offers to handle RECALL initiation to RECALL termination, with lifetime follow-up for your product. Additionally, we handle warning letters and its resolution with transparent correspondence to both agencies and your team. |
| PROJECT MANAGEMENT For your product and team success, RISĒ streamlines project initiation, planning, execution, monitoring, and closures with traceability matrix. | SAFETY SCIENCE Post-Market surveillance and follow-up for your product has never been this easy with RISĒ’s Safety Monitoring Plan (SMP), with timely reporting to the agencies. |
| BIOLOGICAL EVALUATION PLAN (BEP) REVIEW RISĒ provides relevant plans as per ISO 14971 and ISO 10993 standards to demonstrate safety and risk profile for your product. | CLINICAL EVALUATION PLAN (CEP) REVIEW RISĒ provides comprehensive plan for Post-Market Clinical Follow-Up (PMCF), Summary of Safety and Clinical Performance (SSCP), and Safety-Benefit analysis tailored specifically for your product and its needs. |
QUALITY ASSURANCE RISĒ has remarkable understanding of quality standards that can identify discrepant SOPs, Quality Agreements, Supplier Records, CAPAs, Risk Assessments, and update to current regulations for your product and team requirements. | VERIFICATION & VALIDATION (V&V) REVIEW RISĒ excels in delivering faster review timelines for V&V projects with real-time regulatory agency feedback system for regulatory submissions and your product compliance. |
