Service Details
ISO 13485 and MDSAP Quality System
We develop and implement quality management systems according to ISO 13485 for manufacturers, authorized representatives, importers, distributors, and other organizations involved in managing medical devices. We implement MDSAP requirements for manufacturers interested in non-EU markets involved.
Context and Introduction
The implementation of a quality management system allows an organization to demonstrate its ability to provide medical devices and related services that comply with customer and regulatory requirements. It is also a necessary requirement for a manufacturer in the process of conformity assessment of a medical device.
01
Development and implementation
We develop and implement quality management systems according to MDR, ISO 13485, and MDSAP for organizations with established operating methods or those needing support for the implementation of new processes.
02
Maintenance
We support the organization to ensure the maintenance of quality system compliance and the consequent positive outcome of surveillance audits. This includes constant updating of documentation based on periodic analysis of feedback obtained during audits in which we are involved.
03
Audit
We perform internal and supplier audits, including outside the EU, according to MDR, ISO 13485, ISO 9001, and MDSAP with issuance of the audit report and discussion of methods to resolve identified non-conformities. We support the manufacturer during certification and surveillance audits by the notified body, certification body, and competent authority.
04
Surveillance and vigilance
We develop the post-market surveillance plan (PMS plan) and the clinical follow-up plan (PMCF plan). We collect input data for the preparation of reports (PSUR, PMSR, and PMCF report) and manage their impact on technical documentation.
We provide support for vigilance management and reporting of serious incidents.
Contact Us
Needs Analysis
Use the contact details in the contacts section: we can provide more details, arrange an introductory meeting, structure a tailored service, and define a dedicated economic offer.
