06 pillar
Post-Market Support- Sustaining Excellence
Ensure long-term success with continuous improvement and unwavering compliance.
Navigate the journey of post-market success with our Post-Market Support Pillar, designed to keep your product at the forefront. Through ongoing support and optimization, we ensure your device not only meets but exceeds industry standards. Discover how our comprehensive maintenance services can sustain your success and drive continuous improvement.
Post-Market Support Pillar Core Services
- Post-Market Surveillance
- Quality management optimization
- continuous improvement initiatives
- product lifecycle management
- regulatory reporting
- feedback & complaint management
POST-MARKET SURVEILLANCE AND VIGILANCE
Ensuring ongoing safety and efficacy through robust monitoring and vigilance.
Post-market surveillance is critical for maintaining product safety and compliance. Our services include:
- Adverse Event Reporting: Monitoring and reporting adverse events to regulatory authorities.
- Surveillance Planning: Developing comprehensive post-market surveillance plans.
- Data Collection and Analysis: Collecting and analyzing data on product performance and safety.
- Regulatory Compliance: Ensuring compliance with post-market regulatory requirements.
- Risk Management: Identifying and mitigating risks through continuous monitoring and analysis.
Our post-market surveillance and vigilance services help you maintain the safety and efficacy of your products in the market.
QUALITY MANAGEMENT SYSTEM OPTIMIZATION
Enhancing your QMS for ongoing compliance and operational excellence.
Optimizing your quality management system is essential for maintaining high standards. Our services focus on:
- QMS Assessment: Evaluating your current quality management system to identify areas for improvement.
- Process Optimization: Streamlining and enhancing quality processes for better efficiency and effectiveness.
- Documentation Review: Ensuring all quality documentation meets regulatory standards and best practices.
- Training and Development: Providing training to staff on quality management principles and practices.
- Performance Metrics: Developing and tracking key performance indicators to monitor QMS effectiveness.
Our quality management system optimization services ensure your QMS remains robust, compliant, and effective.
CONTINUOUS IMPROVEMENT INITIATIVES
Driving ongoing improvement to enhance product quality and operational efficiency.
Continuous improvement is key to sustaining excellence. Our services include:
- Lean Six Sigma: Implementing Lean Six Sigma methodologies to drive process improvement.
- Root Cause Analysis: Identifying the root causes of issues and implementing corrective actions.
- Process Mapping: Mapping out processes to identify inefficiencies and areas for improvement.
- Performance Benchmarking: Comparing performance metrics against industry benchmarks to identify gaps.
- Kaizen Events: Facilitating Kaizen events to foster a culture of continuous improvement.
Our continuous improvement initiatives help you enhance product quality and operational efficiency over time.
PRODUCT LIFECYCLE MANAGEMENT
Managing your product’s lifecycle to ensure long-term success and compliance.
Effective product lifecycle management is essential for sustaining market success. Our services focus on:
- Lifecycle Planning: Developing comprehensive plans for managing the product lifecycle from launch to end-of-life.
- Change Management: Implementing changes in a controlled and compliant manner.
- Sustaining Engineering: Providing engineering support to address post-market issues and enhancements.
- Regulatory Updates: Ensuring the product remains compliant with evolving regulatory requirements.
- Product Optimization: Continuously improving the product based on feedback and performance data.
Our product lifecycle management services ensure your product remains competitive and compliant throughout its lifecycle.
REGULATORY REPORTING AND COMPLIANCE UPDATES
Staying compliant with evolving regulatory requirements through proactive reporting and updates.
Maintaining compliance requires staying current with regulatory changes. Our services include:
- Regulatory Monitoring: Keeping abreast of changes in regulatory requirements and standards.
- Compliance Audits: Conducting audits to ensure ongoing compliance with regulations.
- Regulatory Reporting: Preparing and submitting required regulatory reports and updates.
- Documentation Updates: Updating documentation to reflect changes in regulatory requirements.
- Training: Providing training on new and updated regulatory requirements.
Our regulatory reporting and compliance update services help you stay compliant and avoid regulatory issues.
CUSTOMER FEEDBACK AND COMPLAINT MANAGEMENT
Leveraging customer feedback to improve products and address issues promptly.
Managing customer feedback and complaints is vital for product improvement and customer satisfaction. Our services focus on:
- Feedback Collection: Collecting feedback from customers through various channels.
- Complaint Handling: Managing and resolving customer complaints efficiently and effectively.
- Root Cause Analysis: Investigating the root causes of complaints to prevent recurrence.
- Continuous Improvement: Using feedback and complaints to drive continuous product improvement.
- Customer Communication: Keeping customers informed about the status of their feedback and complaints.
Our customer feedback and complaint management services ensure that customer concerns are addressed promptly and effectively, leading to better products and satisfied customers.
Solutions for Every Milestone of Your Journey
Commercializing a medical product is a complex and multifaceted endeavor. At Fission, we’ve developed six Market Access Pillars to support every step of your MedTech venture from concept, to your first sales, and beyond.
If you only need a website designed, quality procedures developed, or a full 510(k) submission, we’ve got you covered.
OUR SERVICES
Market Access Pillars
Design & Development
- Project Management
- Usability Engineering
- Design History File Creation
- Verification & Validation
- Risk Management Planning
Clinical Development
- Clinical Protocol Development
- GCP Compliance
- Clinical Evaluation Reports
- Data Integrity & Management
- Post-Market Clinical Studies
Quality Systems & Compliance
- Quality Management Strategy
- Quality Management Systems
- Mock FDA Inspections
- Regulatory Audit Prep
- Compliance Training
Regulatory Affairs
- Regulatory Strategy
- FDA Submissions Support
- Regulatory Gap Analysis
- Global Submission & Registration
- Regulatory Compliance
Commercialization
- Brand Development
- Strategic Marketing Planning
- Content Strategy & Creation
- Digital Marketing
- Social Media Management
Maintenance
- Post-Market Surveillance
- Continuous Quality Improvement
- Product Lifecycle Management
- Regulatory Reporting
- Complaint Management
At Fission Consulting, we’re not just another consultancy—we’re your dedicated partners in navigating the complexities of the medical device industry. With a team of expert consultants spanning all core service areas, we offer unparalleled expertise and guidance at every stage of your journey, from concept to market dominance.
