Answering the need of Manufacturers and Dealers of medical devices and support them in the transition from guidelines to new European Regulations: this is the mission JSB Regulatory Affairs and Pharmacovigilance team.
Our professional a continuous support to Manufacturers, Importers and Distributors is regarding the management and compliance of medical devices processes; starting from a first phase of consulting and identification of regulatory obligations, we manage DM classification, device compliance checks, technical documentation control (Technical File preparation and revision) supervision of notified bodies and management of post-marketing surveillance obligations. One of our expert responsible for regulations compliance and regulatory affairs can be included within the companies that need them.
In particular, when the devices access the market we also provide support in:
- Certification process management for obtaining the CE mark by a Notified Body
- Notification management to health authorities in EU countries
- Notification of medical devices in the database/directory of the Ministry of Health
- Preparation of advertising and, if necessary, authorization request
- Standard Operating Procedures drafting and updating for Materiovigilance activities
- Support in the management of clinical investigations pre-market
- Establishment of operational procedures for manufacturers’ quality systems
- Implementation of quality systems in accordance with ISO13485 (drafting of operating procedures and production of documentation concerning the processes established for quality system maintenance)
- Possible integration of ISO 9001 and ISO 13485 quality systems
For medical devices already commercialized we deal with:
- Implementation of Post-marketing Surveillance (SSPC)
- Support for manufacturers/and authorized representativesfor the management and notification of Incidents (including the follow-up phase and any Corrective Actions) that occurred in EU and non-EU territory
- Support in the management of clinical investigations post-market