Technology Specification and Development

New technologies and innovations fascinate us.

Specification and development of new technologies demands rigorous analysis and effective planning, from the outset, to ensure the needs of all stakeholders are met. In the case of medical products, this encompasses safety and efficacy/performance requirements, and conformance with regulatory standards. We can guide you through this process, thereby reducing the time to market and thus adding value to your technology. Services include:

Early definition of the technology, 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

Creation of ISO 13485 quality systems

CE-marking of medical devices, including compilation of Technical Files

Extension of technology platforms into new uses

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 technology.