MPSS staff have extensive medical product (pharmaceutical, medical device, and diagnostic) development and manufacturing experience. As such, we can provide various types of support in relation to product development, prototyping, testing, as well as identifying and interacting with contract manufacturers. If your product test data will be used for any kind of submission (clinical study or for marketing), your device must be documented according to FDA regulations, as well as having material and manufacturing traceability. For example, per the FDA, investigational devices must be designed and developed in accordance with Design Controls under the Quality System Regulation. MPSS can assist you with meeting these requirements.
The MPSS team is available to meet and assist with any of your needs for guidance on product development, prototyping, cGMP and CMC manufacturing. Please contact us and we will be happy to meet and provide individualized support
- Medical Product Concept Consultation (pharmaceutical, medical device, or diagnostic)
- What is the intended use and indications for use?
- What documentation is needed for submissions?
- What test data is needed for submissions?
- How many/much products are needed and how will these be produced?
- Guide the development process for evaluating new clinical indications for existing medical products
- Early product development regulatory guidance
- Determination of need for an IDE/IND to achieve clinical data
- Informal and formal communication with the FDA to get early input to development and testing strategies
- FDA pre-submission guidance and support
- Manufacturing Guidance
- Liaise with contract manufacturers and test labs to supply needed prototypes, products and services for research and development
- Assist with manufacturing plans and related controls
- ducation and training for product development, supply chain management and manufacturing controls, per FDA cGMP and CMC requirements
- Guidance for Documentation and Planning
- Provide design control support to create needed Design History File documentation for the development of the medical product, including assistance with risk assessment, design inputs, design reviews etc.
- Provide guidance for test strategies including pre-clinical and clinical data for safety and efficacy, as applicable
- Support use of the Vanderbilt Quality Management System to generate needed product development documentation
- Early product development planning and pathways
- Assist with search of industry standards and methodologies for product development and manufacturing
- Provide project assistance and guidance for medical product development and manufacturing
- Administrative Support
- Effort support or administrative support on grants as consultants or co-investigators for planning and product development
- Facilitate trans-institutional collaboration
- Teaching and education in relation to product development and manufacturing