Medical Device Quality Management Systems
At EUmAccess GmbH, we provide expert consultancy to help medical device and in vitro diagnostic (IVD) manufacturers achieve compliance with ISO 13485:2016 and EN ISO 13485:2021. These international standards define the quality management system (QMS) requirements for organizations involved in the design, production, installation, and servicing of medical devices.
What is ISO 13485?
ISO 13485 is the globally recognized quality management system (QMS) standard specifically designed for medical device manufacturers and related industries. Compliance with ISO 13485:2016 or EN ISO 13485:2021 ensures that medical devices meet regulatory requirements, patient safety standards, and quality assurance protocols.
Ensures compliance with EU MDR (2017/745) & IVDR (2017/746)
Enhances product safety, quality, and risk management
Required for CE Marking and medical device regulatory approvals
Improves efficiency, traceability, and regulatory compliance
ISO 13485:2016 vs. EN ISO 13485:2021
| Standard | Scope |
| ISO 13485:2016 | International version applicable globally |
| EN ISO 13485:2021 | European version harmonized with EU MDR & IVDR, containing additional Annexes Z that align with EU regulations |
EN ISO 13485:2021 is essential for manufacturers targeting the European market, as it aligns directly with EU MDR & IVDR.
Our ISO 13485 Consultancy Services
ISO 13485 Implementation & Certification Support
- Assisting manufacturers in setting up an ISO 13485-compliant QMS
- Preparing documentation, policies, and standard operating procedures (SOPs)
Internal Audits & Gap Analysis
- Identifying non-conformities and preparing for certification audits
- Conducting internal audits to ensure ongoing compliance
Regulatory Compliance & CE Marking Support
- Aligning ISO 13485 QMS with EU MDR 2017/745 & IVDR 2017/746
- Supporting manufacturers with CE Marking and Notified Body interactions
Training & Awareness Programs
- Providing training sessions for teams on ISO 13485 implementation, risk management, and documentation requirements
Who Needs ISO 13485 Certification?
Medical Device & IVD Manufacturers
Contract Manufacturers & Suppliers
Distributors & Importers
EU Authorized Representatives (E.A.R.)
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.