ISO 13485 FOR MANUFACTURERS
Enough to Ensure Quality Credibility of Your Medical Devices with ISO 13485 For Manufacturers.
If you are a medical device manufacturer in the United Arab Emirates, then you have probably heard of ISO 13485—the international standard for medical device quality management systems. But is it enough to ensure the quality and credibility of your products? The answer is yes, and more!
Above & Beyond: How ISO 13485 Uplifts Medical Manufacturers In UAE?
ISO 13485 For Manufacturers helps not only maintain the safety and effectiveness of your medical devices but also to demonstrate that you are complying with applicable regulatory requirements. It provides a structure for designing and manufacturing safe products, as well as all applicable aspects of storage and distribution.
It also ensures that your personnel have the necessary qualifications, training, and skills to support their roles and responsibilities. The certification is designed to ensure that medical device manufacturers have a system in place to consistently produce safe and effective products that meet customer and regulatory requirements.
A certificate granted by the International Organization for Standardization (ISO) is an internationally recognized seal of approval that establishes an effective quality management system. With this seal of approval, medical device manufacturers in UAE can attain higher levels of customer confidence and better position themselves in today’s competitive market.
What Does An ISO 13485 Certification In UAE Entail?
One way a medical device manufacturer can make sure that their products are of high quality, safe, and compliant with international standards is by obtaining an ISO 13485 documentation in UAE. This is a quality management system for the design and manufacture of medical devices, ensuring that manufacturers have met customer needs and legal requirements.
When it comes to ISO 13485 For Manufacturers in UAE, there are four main stages:
Stage 1 – Establishing a Quality Management System
This stage involves setting up the quality management system according to medical device regulations and relevant standards. All manufacturing processes must be understood and written down before the certification can be issued.
Stage 2 – Regulatory Appraisal & Evaluation
To get certified, the manufacturer must have their products appraised by regulatory bodies to ensure they meet safety standards. The results of this appraisal will determine if the manufacturer is allowed to proceed with certification.
Stage 3 – Internal Audit & Documentation Verification
In this stage, a thorough audit is conducted to ensure all documentation meets ISO 13485 standard requirements and rules. The internal auditor will review any discrepancies and offer corrective actions if needed.
Stage 4 – Certification Auditing & Issuance Of Certificate
The fourth stage is when the audit results are passed on to the certifying body which will carry out one final check before issuing the certificate. After the successful completion of this process, your medical device manufacturing company is officially ISO 13485 certified in UAE!
Is ISO 13485 For Manufacturers Enough for Medical Device Manufacturing Process In UAE?
The million-dollar question is – Is ISO 13485 Enough for Your Medical Device Manufacturing Process?
To answer this, you need to understand that ISO 13485 is essentially a response to the industry’s need for compliance with regulatory standards. In other words, ISO 13485 serves as a benchmark for meeting those standards and providing medical device manufacturers with the necessary administrative and operational processes for quality management.
To be able to have confidence in the quality of your products, you need more than just a certification for compliance. You must build on top of it with an operating system that is robust, dependable, and able to maintain consistency. That’s where more specific requirements come in. The following are essential features of a quality system:
- Documented processes & procedures (including risk management and safety)
- Traceability processes & procedures
- Quality control & performance monitoring systems
- Training processes & programs
- Validation and verification activities
All these features must be considered if you want your medical device production process to meet regulatory standards and pass product safety tests. This can only be achieved if you go beyond just ISO 13485 Certification, but also use other best practices related to its implementation.
For medical devices that are being manufactured in the UAE, Ascent Emirates can help manufacturers obtain ISO 13485 and other ISO Certification in Dubai. We have extensive experience in certification services and we serve clients across the UAE and beyond. Call us now for an immediate consultation.