PALOMA LOPEZ-GUERRERO

At EpisKey Medical Consulting (paloma.lopez@episkeymedical.com) we work with a team of specialists with extensive experience in medical devices, and with a great desire to collaborate. We carry out projects that deal with obtaining the distribution license for medical devices, applying for the CE marking required for a medical device to be marketed in the European Union or training our clients to act as Technical Responsible for their product. Medical device consulting encompasses the development of regulatory strategies. This includes assistance in identifying the product’s risk class and designing the most appropriate strategy to obtain the clinical evidence necessary to achieve CE marking. The first step is to ensure that the manufactured product is indeed a medical device. Then, we proceed to classify it according to the level of risk. To gather clinical evidence, different paths can be followed, including clinical research, entry strategy planning, and the development of marketing materials that comply with advertising regulations. Consultants can offer advice on how to position a product in a competitive market, manage intellectual property, and comply with advertising and promotion regulations. We offer the elaboration of Clinical Evaluation Plans,·Clinical evaluation reports and performance evaluation. We help to find the best clinical strategy. We also elaborate Quality Management Systems based ISO 13485 and ISO 9001. Internal audits: initial analysis and follow-up. We Complete technical documentation for obtaining the CE marking. Non-Medical Devices:·Production of technical documentation for the marketing of Annex XVI products and quality systems. Regulatory Strategy: Regulatory feasibility studies, cost studies, entry strategies in third countries.