We can provide a range of consultancy services for medical devices including product development, clinical research, regulatory affairs and vigilance
We provide a wide range of consultancy services for medical devices, including product development, preclinical and clinical consultancy, regulatory affairs and quality assurance as well as post-marketing aspects such as vigilance.
Our consultants will be pleased to assist with planning R&D programmes for novel products. This includes designing suitable studies to meet regulatory requirements and achieving timely approvals in the countries of interest. We can also complete quality audits of companies, their suppliers and subcontractors by our certificated lead auditors.
In the case of drug-device combinations, we have assisted many clients in the development of their products; planning the studies required for multinational launches and in establishing satisfactory quality systems. We have considerable experience with the registration of such products with both drug and device regulatory authorities.