01 pillar
Design and Development – Innovate with Precision
From concept to creation, we guide you through every step of the design and development process.
Explore our Design and Development Pillar, one of our core service offerings, where ideas meet execution. Together we will transform your vision into tangible results. Keep scrolling to discover the blueprint for your next breakthrough.
Design and Development Pillar Core Services
- Project Management
- Usability Engineering
- Design History File Creation
- Verification & Validation
- Risk Management Planning
PROJECT MANAGEMENT
Expert oversight and coordination to ensure timely and efficient execution of design projects.
Project management is the backbone of successful medical device development. Our expert project managers provide meticulous oversight and coordination to keep your project on track from inception to completion. We focus on:
- Timeline Management: Creating and adhering to detailed project schedules to ensure timely delivery.
- Resource Allocation: Efficiently managing resources, including team members, budget, and materials.
- Milestone Tracking: Setting and achieving key milestones to monitor progress and maintain momentum.
- Risk Management: Identifying potential obstacles early and implementing strategies to mitigate them.
- Communication: Facilitating clear and consistent communication among all stakeholders to ensure alignment and transparency.
By integrating best practices in project management, we ensure your medical device development progresses smoothly, efficiently, and cost-effectively.
USABILITY ENGINEERING AND HUMAN FACTORS ANALYSIS
Incorporation of user-centered design principles to optimize device usability and safety.
Usability engineering and human factors analysis are crucial for creating medical devices that are safe, effective, and user-friendly. Our services include:
- User Research: Conducting thorough research to understand the needs and limitations of end-users.
- Prototyping and Testing: Developing prototypes and conducting usability tests to gather feedback and refine designs.
- Ergonomics: Designing devices that are comfortable and intuitive to use, reducing the risk of user error.
- Interface Design: Creating clear and easy-to-navigate user interfaces for software components.
- Regulatory Compliance: Ensuring that designs meet regulatory standards for usability, such as IEC 62366.
By focusing on the user experience, we help you develop devices that not only meet regulatory requirements but also delight users and improve patient outcomes.
DESIGN HISTORY FILE CREATION
Comprehensive documentation of the design and development process to meet regulatory requirements.
A well-maintained Design History File (DHF) is essential for regulatory approval and compliance. Our DHF services include:
- Documentation Strategy: Developing a comprehensive strategy for capturing and organizing design documentation.
- Traceability Matrices: Creating matrices that link design inputs to outputs, ensuring all requirements are met.
- Change Management: Documenting and managing design changes to maintain a clear history of development.
- Regulatory Submission: Preparing documentation that meets the requirements of regulatory bodies like the FDA and ISO.
- Audit Preparation: Ensuring your DHF is audit-ready, with all necessary documentation easily accessible and well-organized.
Our meticulous approach to DHF creation ensures that your design process is fully documented, facilitating smoother regulatory reviews and audits.
DESIGN VERIFICATION AND VALIDATION
Rigorous testing and analysis to confirm that the device meets design specifications and user needs.
Design verification and validation (V&V) are critical steps in ensuring your medical device is safe, effective, and ready for market. Our V&V services include:
- Timeline Management: Conducting tests to confirm that the device design meets specified requirements.
- Validation Studies: Performing studies to ensure the device fulfills its intended use in real-world conditions.
- Test Protocols: Developing detailed test protocols and procedures to guide verification and validation activities.
- Data Analysis: Analyzing test data to identify any issues and implement necessary improvements.
- Compliance: Ensuring all verification and validation activities comply with relevant regulatory standards.
By rigorously verifying and validating your device, we help you bring a reliable and compliant product to market with confidence.
RISK MANAGEMENT PLANNING
Identification, assessment, and mitigation of potential risks throughout the product lifecycle.
Effective risk management is essential for ensuring the safety and efficacy of medical devices. Our risk management services encompass:
- Risk Identification: Identifying potential hazards and risks associated with the device, its components, and its intended use.
- Risk Assessment: Evaluating the severity, likelihood, and detectability of identified risks to prioritize them for mitigation.
- Risk Mitigation: Developing strategies to reduce or eliminate identified risks through design controls, process improvements, or user safeguards.
- Risk Control: Implementing controls to manage residual risks and prevent harm to patients or users.
- Risk Monitoring: Continuously monitoring and reassessing risks throughout the product lifecycle to address emerging threats or changes in circumstances.
By proactively managing risks, we help you minimize the likelihood of adverse events, regulatory issues, and costly recalls, ensuring the success and longevity of your medical device in the market.
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 Report
- 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 Submissions & Regulation
- 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.
