A commitment to life sciences innovation compliance and suitability
ISO EN 13485 is an exclusive project to help potential clients globally
Ensuring Quality and Compliance in Medical Devices
At isoen13485.com, we specialize in providing comprehensive consultancy services for ISO 13485, the international standard for quality management systems in the medical device industry.
Consultancy
Our goal is to help your organization achieve and maintain compliance with ISO 13485.
Implementation Tools
We offer a range of tools designed to simplify the implementation and maintenance of ISO 13485:
Trainings
Specialized training for awareness, implementation, internal auditing & lead auditing.
Internal Audits
Thorough internal audits to ensure ongoing compliance and readiness for certification.
Project Management
We treat each and every client with a well planned project on the agreed scope of work.
Team Development
Our approach focuses on team building and empowerment so that the role of consulting is focused on developing your team.
An array of resources
Our comprehensive suite of professional services caters to a diverse client needs, ranging from just starting off to surveillance non-conformities support.
Gap Analysis
- Assess Current State
- Identify Gaps
- Develop Action Plan
Specialized Trainings
- Understand the standard’s concepts & principles.
- Learn how to develop and implement a Quality Management System.
- Key principles for effective QMS audits.
“At ISOEN13485, we empower organizations to achieve excellence in quality management, ensuring compliance with ISO 13485 standards for safer, more effective medical devices.”
S.M. Waqas Imam
CEO, ISO EN 13485
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