Regulatory Affairs and Quality Assurance of Medical Device

Abstract

The regulatory affairs (RA) department of a Medical Device company is responsible for obtaining approvals for new products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. The department serves as the interface between the regulatory authority and the project team. It is also the channel of communication with the regulatory authority as the project moves forward. The goal is to correctly anticipate the needs of the regularity authority in order for the product to seek approval. It is the responsibility of RA to stay on top of current legislation, changes, guidelines and other regulatory intelligence. The RA department plays an important role in helping the project team understand the regulatory needs and work accordingly. The purpose and principles of RA were studied, and the framework of legislation was understood that helped in understanding the process of working with project teams and interacting with the regulatory health agencies. An important proactive task of the RA is to provide input when legislative changes are being discussed and proposed. European Union – Medical Device Regulation (EU-MDR) is the new legislation that will come into force in May-2020. The EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC) are being replaced by EU-MDR. In order to understand the development process and to discuss the divergence of guidelines, the detailed study of Medical Device Directive is being done. Further, in-depth study of new directive i.e. EU-MDR is being done to know the new requirements for the new devices intended to be marketed in Europe (EU). Also, determination of EU Importer was done under EU – MDR Project to identify the supply chain in Corporate Division. In Stryker Orthopedics Division (Joint Replacement), three requests of regulatory documents for country specific registration purposes were handled in Global Product Registration Database (GPRD). This database is the platform to request and exchange regulatory documentation between Design Division RA and Distribution Division RA for registration purposes. PTC Integrity Lifecycle Manager (software) is a system that was used to create templates for design and risk control documents within Stryker Hardware Instance Lifecycle Manager. The use of this software is required for all new product development products projects to increase accuracy and efficiency. Divisional Customer Complaints process and the relationship between the associated procedures were handled which includes complaints associated with manufactured medical devices by all Joint Replacement manufacturing facilities. Complaint Intake by following the CIC protocols, its management by following the CMC protocols and further Investigation was done by following the PAC protocols. In Orthopedics Division, all complaints are handled using Trackwise database. This is used to manage complaints (“Product Inquiries”), Medical Vigilance Reports (“MDVs”), and Medical Device Reports (“MDRs”) associated with medical device.