Product R&D & Project Management


Our product R&D and project management services cover the whole project, from initial concept development through to regulatory clearance for Europe, United States, and China. We specialise in supporting start up Medical Device companies, helping clients to bring new innovative ideas to life, while maintain control of every aspect — quality, cost, progress, delivery and safety.

Our professional, collaborative and agile management style promotes effective working relationships between all parties. We work internationally and can tailor project solutions to your need.

Services we provide include:

• Project planning
• Feasibility studies

Regulatory Classification/Roadmap

• Product Design and Development
• Design Transfer to Manufacturing
• Clinical Evaluation
• Technical Documentation
• CE Marking, FDA and CFDA approval
• Programme management

Quality and Regulatory Support

We provide quality and regulatory support to various size Medical Device companies depending on your need.  Our team has extensive experience in ISO9001, ISO13485, ISO17025, 21 CFR Part 820, as well as Medical Device Directive/Regulation, and associated FDA requirements.

Services we provide include:

• Internal Audits, Supplier Audits
• Preparation and handling of FDA, Notified Body Audits
• Quality Management System implementation to ISO9001:2015, ISO13485:2016, and FDA 21 CFR Part 820
• Clinical trial documentation, including management of Competennt authroity approval and Ethic approval
• Process Development, Management and Improvement
• Technical Documentation
• Prepare regulatory submissions for CE Marking, FDA and CFDA approval

Fund Raising

We can also assist UK start up companies raise funding  through our well connected network.