Quality aspects for medical devices, quality system and certification process

Medical Devices (MDs) are nowadays every time more and more important in the healthcare industry and the related processes for worldwide regulation and certification are a topic of great interest. In particular, the need for regulation harmonization between European Countries (European Regulation), as well as worldwide, is very important both for Regulatory Authorities and for the industry world. This article covers a typical process for an MD development and industrialization phase, providing some case studies and taking into consideration all steps from design up to start-up of the production phase and process validation. All these activities are necessary for the product certification process. The discussion emphasizes the aspects related to the Quality System, Production, Validation and Quality Control, proposing an integrated approach, which combines the GMP and ISO requirements (e.g., ISO 13485 and ISO 14971), following a Quality Risk Management (ICH Q9) and, where applicable, an integrated Pharmaceutical Quality System (ICH Q10) structure. (C) 2017 Elsevier B.V. All rights reserved.