Easy13485+: Integrated QMS/ISMS for MedTech SMEs
Easy13485+
Integrated QMS/ISMS for MedTech SMEs
MDR certification of software medical devices rarely fails in the core quality management area.
It fails in conformity assessment, CE marking and the Product Life Cycle — exactly where software, risk, usability and product-related standards need to be connected on process level.
This is where Easy13485+ comes in: an integrated QMS/ISMS for MedTech SMEs that moves standards traceability from the manual level to the process level.
Where MDR certification becomes critical
MDR certification of software medical devices does not usually fail because the core QMS is missing.
The real challenge appears in conformity assessment and CE marking. This is where the Product Life Cycle becomes decisive.
Software development, risk management, usability engineering, technical documentation, cybersecurity and validation evidence all need to be connected in a way that can be audited.
If these links only exist in templates, manual tables or the minds of the project team, the audit becomes harder than it needs to be.
Easy13485+ addresses this challenge directly by connecting regulatory requirements with the processes where they are actually implemented.
Standards traceability on process level
Easy13485+ is designed as an integrated QMS/ISMS for MedTech SMEs.
Instead of keeping standards traceability mainly on manual level, Easy13485+ moves it to the process level.
The system includes 619 auditable norm mappings. These mappings are bidirectional – from the requirement to the process card and from the process card back to the regulatory basis.
This makes traceability easier to understand, easier to maintain and easier to verify in audit situations.
For software medical devices, this is especially relevant. MDR, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1, IEC 82304-1 and ISO/IEC 27001 do not work as isolated islands. They need to be connected throughout the Product Life Cycle.
Transparent verification instead of perfection claims
A whitepaper that claims perfection is less valuable than one that shows its open points.
That is why the internal verification result is disclosed openly:
0 Major.
2 Minor.
3 Observation.
The findings do not affect the regulatory norm coverage. They concern technical auditability topics such as deeplinks, key fields and description hygiene.
This transparency is important. It shows that Easy13485+ is not presented as a theoretical promise, but as a system that is reviewed with the same seriousness expected in regulated MedTech work.
Download the full whitepaper
The complete whitepaper V4.7.1 explains the architecture, norm coverage, process traceability, ISMS integration and internal verification results in detail.
Unser
Service Portfolio
Pragmatische Unterstützung für MDR und ISO 13485 – vom Prototyp zur marktreifen Lösung.
Externer QMB & Interne Audits
Auditfestes ISO-13485-System – mit klaren Befunden und wirksamen CAPAs.
Projekt Management
Komplexe Projekte stabil führen – bis Meilensteine wirklich erreicht sind.
Klinische Bewertung (MDR)
Klinische Evidenz ordentlich aufbauen – passend zu GSPR und PMCF-Erwartung.
Technische Dokumentation (MDR)
DHF/TF strukturiert aufsetzen – Lücken schließen, Nachweise finden. Prüffähige Struktur nach Anhang II.
Regulatory Affairs
Regulatory aus einer Hand – von Submission bis Change Control. Pragmatisch, fristgerecht und dokumentiert.
Prozessberatung (ISO 13485 / MDR)
Schlanke Prozesse, die im Audit funktionieren – und im Alltag laufen.
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