Easy13485 4.7.0 : Start lean. Add ISMS when it matters
Easy13485 4.7.0
Add ISMS when it matters
Not every MedTech startup needs ISO/IEC 27001 from day one.
But if you build SaMD, connected devices or hospital-facing systems, information security maturity will become relevant sooner than many teams expect.
With Easy13485 4.7.0, we focused on one key question:
How can an ISMS become auditable without creating a second management system universe?
What we added and improved
With Easy13485 4.7.0, we added and improved several ISMS-related elements:
- ISMS objectives and dedicated register
- explicit ISMS assessment in Management Review
- stronger ISR responsibilities for controls, evidence and ISMS records
- ISMS Manual as a guide through requirements, processes and templates
- CIA-based assessment for process software, IT processes and IT equipment
- Threat Monitoring as a repeatable PMS activity
- information security incidents integrated into complaint handling
- clearer tracking of cybersecurity measures: product evidence via design control, process evidence via control register
ISO 13485 remains the regulatory backbone
The idea is simple:
ISO 13485 remains the regulatory backbone.
ISO/IEC 27001 maturity can be added when your product, customers, hospitals, insurers or partners require it.
This approach allows MedTech startups to start lean and add ISMS maturity when it becomes relevant for the product, the customer environment or the market requirements.
Relevant for SaMD and connected medical devices
If you are building SaMD or a connected medical device, one important question is:
When does ISMS become relevant for our QMS?
Easy13485 4.7.0 addresses this question by connecting ISO 13485 with information security maturity in a structured way.
The goal is not to create a second management system universe, but to make ISMS elements auditable within the existing QMS logic.
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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