Quality

ISO 13485 Implementation

Development of a new or modification of existing quality management system for medical devices in full conformity to ISO 13485. We offer ready-made systems, as well as custom options tailored to your organisation needs.

Alignment with US FDA QMSR (21 CFR Part 820)

Modification of your exiting QMS to comply with FDA´s new Quality Management System Regulation. Our team will implement the specific FDA additions such as record-keeping or reporting obligations.

Post-Market Surveillance

MDR-compliant systems for device performance monitoring, event reporting, trend analysis, and vigilance.

MDSAP Audit Preparation & Integration

We open the door of your organisation to global markets access by preparing you for MDSAP audits. Our service integrates the requirements of multiple regulatory authorities (Australia, Brazil, Canada, Japan, U.S.) into a single, efficient audit-ready QMS.

Internal and External Audits

Internal, self-assessments conducted by the company to check if their quality management system meets requirements and is effective. External, conducted by third parties like Notified Bodies or regulatory authorities.

Quality Management System (QMS)

MDSAP (Medical Device Single Audit Program) is a collaborative program involving regulatory authorities from countries such as the US (FDA), Canada, Brazil, Australia, and Japan, designed to streamline oversight of medical device manufacturers. It allows a single, harmonized audit of a manufacturer's QMS based primarily on ISO 13485:2003 to satisfy the requirements of multiple participating authorities, reducing the need for redundant audits and minimizing business disruptions.