Product Specification and Development
Specification and development of medical products demands rigorous analysis and effective planning from the outset, to ensure they meet safety and efficacy/performance requirements, and conform to regulatory standards. We can guide you through this process, thereby reducing the time to market, and thus adding value to your product. Services include:
- Early definition of the product, based on stakeholder requirements
- Design control and verification, including risk management and design reviews
- Formulation and management of project schedules with clearly defined tasks and milestones for each stage of the process
- Assistance with regulatory submissions, including those for clinical trials
- Design preclinical/biocompatibility and stability programmes
- Developing new uses and indications for existing compounds
- Facilitate R&D and technology transfer collaborations and joint ventures
- Identify and secure out-sourcing partners
- A particular expertise in clinical research, including training in how to design, conduct and manage studies.
Please contact us to discuss the development of your product.