ISO 13485
with ComplyEncrypt
ISO 13485 sets quality management requirements for medical devices and related services, with a focus on consistently meeting customer and applicable regulatory requirements.
Not available to buy yet. No launch date or price has been announced.
New to ISO 13485?
Understand the requirements, responsibilities and practical first steps.
Who this is for
Medical-device manufacturers and related product and service organizations
Medical-device teams need more than a general quality manual. Product processes, records, supplier controls and risk-related decisions must fit their device activities and regulatory context.
The requirements
What ISO 13485 asks of your organization
Device-specific QMS
Define the QMS around relevant medical-device activities and applicable requirements.
Controlled processes and records
Maintain appropriate document, record and product-process controls.
Risk and supplier oversight
Address product-related risks and controls over purchased products and services.
The planned ComplyEncrypt pathway
A structured approach to medical-device quality management
The roadmap pathway is intended to organize device-QMS documentation, controlled records and supplier-oversight evidence. It is not available today and would not replace device-specific regulatory expertise, product validation or market authorization.
Intended documentation scope
- Device-QMS documentation
- Document and record controls
- Product-process and risk records
- Supplier evaluation records
Your team remains accountable
The roadmap describes intended functionality, not a currently available module. Documents must reflect your real processes. Your team implements controls, verifies evidence and manages ongoing obligations.
ISO certification is a separate assessment by a certification body. ComplyEncrypt does not issue certificates or guarantee certification.
On the roadmap
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