Quality Services
We provide support with Quality Management System creation, implementation and maintenance
We assist clients in achieving this integration, facilitating the development, implementation, and upkeep of ISO 13485-compliant QMS to meet regulatory standards. Achieving ISO 13485:2016 certification is crucial, but alignment with MDR and IVDR requirements requires additional considerations.
We specialize in creating, implementing, and maintaining Quality Management Systems (QMS) for manufacturers.
MDR and IVDR have introduced some additional QMS expectations:
we support you to reach compliance with new requirements for:
- 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
We design and perform tailored training programs
Our focus is on ISO 13485 requirements aligned with the European Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. We provide customized on-site and off-site training programs tailored to address each client's specific needs concerning quality aspects related to the MDR and IVDR.
Our expert Quality team offers specialized training services in the Quality and Regulatory domains for MedTech companies.
We support you 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