What is ISO 13485 Certification in Saudi Arabia
ISO 13485 certification in Saudi Arabia standard – quality management systems (QMS) for medical devices for regulatory purposes. The latest ISO 13485:2016 specifies guidelines for implementing a quality management system that consistently ensures customer satisfaction and compliance with regulatory requirements. The ISO 13485 standard provides a practical framework to meet the comprehensive needs for a medical device quality management system in Saudi Arabia.
Medical device manufacturers should appoint an experienced ISO 13485 consultant to work on all risk-class devices. Organizations must monitor the safety and risk information during the product life cycle per ISO 13485 requirements.
What do we do as ISO 13485 Medical Device Consultants in Saudi Arabia?
We guide our clients in designing and implementing QMS by:
- Identifying regulatory requirements as per the class of the device
- Defining the documentation required in the process.
- Providing training on QMS.
- Establishing standards stage-wise.
ISO 13485 Certification in Saudi Arabia Standard Benefits
- Obtain certification to gain access to more markets around the world.
- Please describe how your organization can review and improve its processes.
- Monitor supply chain performance, increase efficiency, and cut costs.
- Show that your medical devices are safer and more effective.
- Customer expectations and regulatory requirements must be met.
The ISO 13485 standard allows manufacturers to develop quality management systems that ensure the effectiveness of their processes. They can ensure consistent medical device design and Development, producing, installing, and ensuring safe delivery of medical devices and related services.
As an ISO 13485 certification consultant in Saudi Arabia, we identify the specific regulatory requirements for the product, such as MDR and FDA 510(k), during the implementation.
Requirements of ISO 13485 2016 Certification
Unless otherwise specified, the requirements of ISO 13485:2016 apply to all organizations, regardless of size or type. Any conditions that apply to medical devices also apply to associated services provided by the organization.
The new ISO 13485 2016 focuses on how companies should manage risk-based decisions related to purchasing, design, Development, manufacturing, production control activities and other aspects of the quality management system.
While implementing the system, it is necessary to know the local applicable regulatory requirements per Saudi Arabia’s norms and any additional regulatory requirements you may have to comply with due to an export of the product. When designing the QMS as per ISO 13485, it is also necessary to understand the size of the company, the risk classification of the product and applicable exclusions and non-applicability.
Why Choose Factocert Strategist as ISO 13485 Certification in Saudi Arabia Medical Device Consultant for Your Organization?
We follow a well-defined work methodology for organized working, which leads to zero errors and higher efficiency, which assures meeting customer requirements timely and as per defined QMS Certification Standards. We set up a step-by-step process for zero errors. First, we provide a screen-sharing module that helps manufacturers create documents such as SOPs, Quality manuals, Process validation documentation, etc. After that, we provide assistance and training to ensure the system is adequately implemented.
We are a medical device regulatory consultant in Saudi Arabia, assisting clients in maintaining a compliant system and continual preparedness for audits. Our presence and experience of working in many countries ensure the audit of your organization will be carried out as per the requirement of Saudi Arabia, and you will get error-free deliverables.
Why Factocert for ISO 13485 Certification in Saudi Arabia
We provide the best ISO consultants in Saudi Arabia, Who are very knowledgeable and provide the best solution. And to know how to get ISO certification in the . Kindly reach us at contact@factocert.com. ISO Certification consultants work according to ISO standards and help organizations implement ISO certification in with proper documentation.
For more information visit: ISO 13485 certification in Saudi Arabia
