Quality Services
Quality Management System design, implementation and maintenance
We specialize in creating, implementing, and maintaining Quality Management Systems (QMS) for manufacturers.
We support you to reach compliance with new requirements
MDR and IVDR have introduced some additional QMS expectations:
Post-market Surveillance (PMS)
Periodic Safety Update Report (PSUR)
Incidents and Field Safety Corrective Actions (FSCA)
Resource Management / Supply Chain
UDI and Labeling
Regulatory Compliance
Document Storage Retention
General Safety and Performance Requirements (GSPR)
Implantable Devices
Clinical Evidence
Economic Operators
EUDAMED database
Tailored training programs
We ensure seamless operational execution
Comprehensive support
for the following quality activities
Compliance with ISO 13485, MDR and IVDR requirements related to the Quality Management Systems (QMS)
Quality documentation review and Gap Analysis
Implementation, maintenance and gap remediation of your QMS
Management and resolution of CA/PA
Internal audits
Suppliers’ qualification audits
Support during Notified Body audits
Compliance with FDA 21 CFR part 820 – Quality System Regulation
Tailored training on MDR, IVDR and quality-related aspects
