ISO 13485 | Redvey

What Is ISO 13485?

ISO 13485 is a standard or certification framework designed to establish a quality system tailored to manufacturers and suppliers of medical devices and supplies. Redvey helps the organization understand the requirements and implement them in a practical way tailored to its activities and size, without unnecessary complexity.

Who Is It For?

Owners, managers, and decision-makers of pharmaceutical companies.

Key Benefits

Increase the confidence of customers and contracting parties.
Improve process organization and reduce errors.
Maintain clear documents and records for inspections and audits.
Improve employee competence and clarify responsibilities.
Support expansion opportunities and access to new markets or tenders.

Redvey Services for This Standard

Gap Analysis

Assess the current situation against ISO 13485 requirements and identify the required actions.

Documentation Preparation

Prepare the policies, procedures, forms, and records required for implementation.

Training

Train management and employees on the standard’s requirements and their roles within the system.

Internal Audit

Review the organization’s readiness before the external audit and identify findings.

Corrective Actions

Help close nonconformities and improve system effectiveness.

Readiness Support

Conduct a final review of documents and records before the certification-body visit.

Implementation Steps

Initial meeting to define the certification scope.
Collect available information and documentation.
Prepare a gap-analysis report and implementation plan.
Prepare the required documents and forms.
Train the team on implementation.
Conduct the internal audit and close findings.
Prepare for the external audit.

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