Welcome to MoreMediTech!
Since our inception in 2024, MoreMediTech has been dedicated to providing top-notch medical device consultation services. Our mission is to support the medical device industry and material supplier with comprehensive and reliable expertise, ensuring safety and compliance at every step.
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What we do
Expert Consultation on Medical Device development and MDR Regulations.
We are committed to providing access to affordable and innovative research solutions.
Our products and consulting services are spread across our core businesses of medical device industry includes system engineering, regulatory compliance, Design quality engineering, Validation and verification, reliability, Biocompatibility, material science, toxicology, chemistry solutions, vendor search, and cost reduction processes around the world.
We work providing solution full or part wise depending on customer needs.
We do background research and provide a accurate and unique solution to every problem.
We are investing in businesses of the future digital healthcare, biological safety of medical devices, Advance analytical solutions, advanced robotics, AI, data science etc.
Evaluating large and diverse portfolios
Diagnostic Devices (Ultrasounds, MRI, CT scanner), Therapeutic Devices (Dialysis machines), Surgical Devices (Robotics surgical system), Life Support Devices (Ventilators, Sleep devices), Implantable Devices (Orthopedic, Dental), Single-Use Devices (Catheters).
Consultation on New Medical Device Product Development
Our expert consultation services for new medical device development guide you through every step, from concept to market. We help navigate regulatory requirements, ensure compliance, and optimize design for safety and efficacy. Partner with us to bring your innovative medical device ideas to life with confidence and precision.
Consulting
Services
Biocompatibility
Consultation on the Writing, Review, and Assessment of the following, among other areas:
* Biological Evaluation Plans (BEPs)
* Biocompatibility Summary and Risk Assessment Report
* Chemical Characterization Testing
* Toxicological Risk Assessment
* Gap Assessments
* Regulatory Compliance Support
* Material and Manufacturing Process Evaluation
* Product Safety and Liability Support
* Complaint data analysis and reporting
Material Science
Assisting with Material Selection, Preparation, and Review of Material Evaluation Summaries in relation to the following points:
* Regulatory and Compliance Considerations
* Mechanical Properties
* Chemical Characterization
* Extractables and Leachable Testing
* Bio Compatibility and Toxicological Risk Assessment
* Supplier Evaluation and Management
* Failure Analysis and Troubleshooting
* Lifecycle Management
Toxicological Risk Assessment
Consultation on the Writing, Review, and Assessment of Toxicological Risk Assessment of Medical Devices
* Comprehensive toxicology
* Hazard, and risk assessment
* Toxicological risk assessments
* Scientific and medical writing services
* Establishing health-based exposure limits
Regulatory Compliance
Consultation on Regulatory Compliance
* General Safety and Performance Requirements (GSPR)
* Clinical Evaluation and Investigation
* Technical Documentation
* Quality Management System (QMS)
* Post-Market Surveillance (PMS)
* Vigilance Reporting
* Unique Device Identification (UDI)
* Notified Body Involvement
* Labeling and Instructions for Use
DHF Remediation
* Gap Assessment
* Technical Documentation Update
* Risk Management File
* Usability Engineering File
* Biological Evaluation
* Design Verification and Validation
* Labeling and IFU
* Clinical Evaluation
* Post-Market Surveillance (PMS)
* Notified Body Interaction
Achieving Tangible Outcomes
Our specialized consultation services in biocompatibility, toxicological risk assessment, and material evaluations ensure your medical devices comply with rigorous regulatory standards. We support you throughout the development process, offering sustainable solutions and thorough responses to FDA inquiries, helping your innovations reach the market swiftly and safely.
