ISO 13485 Certification in Myanmar an International Standard outlines requirements for a Quality Management System (QMS) for medical devices. In many global markets, getting market authorization for a medical device requires a QMS that meets the requirements of this standard.
The International Organization for Standardization (ISO) is a non-governmental organization with 165 member nations. The shared technical, industrial, and commercial standards defined by ISO enhance worldwide trade. These standards outline quality management systems (QMS) that enable firms across industries to manufacture safe, dependable goods. ISO standards correlate closely with the regulatory requirements of its member countries, making it easier for ISO-certified enterprises to reach the worldwide market.
ISO 13485 is a quality management system specifically designed for medical device manufacturers. It demands businesses to develop manufacturing methods that limit risk at every step and provide thorough quality verification documentation throughout the production cycle.
What does ISO 13485 quality management entail?
The production of replacement parts is a complex, multistep procedure. Elite Biomedical Solutions, for instance, specializes in the infusion moulding fabrication of replacement parts for devices such as the BD Alaris IV pump. Before market production, the creation of a replacement part, such as a rear assembly case for the Alaris 8100, involves four phases. These consist of:
- Validation testing
- Product launch
Multiple team members contribute to multiple complex processes during each phase. A product’s quality depends on the accurate execution of every function in the production cycle, down to the smallest detail. The ISO 13485 Certification in Myanmar QMS rules reduce mistakes and enhance the identification of design faults and product irregularities that may result in device failure or adverse patient events.
How are ISO 13485 Certification and ISO 9001 Certification in Myanmar different?
Numerous manufacturers of OEM device components hold ISO 9001 Certification in Myanmar. This is a positive development. However, ISO 9001 Certification in Myanmar is a universal standard applicable to all industries. It focuses primarily on methods that guarantee client satisfaction.
However, biomedical equipment serves a role quite distinct from other gadgets. Indeed, consumer happiness is crucial. But the quality and risk reduction might be a matter of life and death for daily-used clinical equipment in patient care.
ISO 13485 Certification in Myanmar contains the same fundamental standards as ISO 9001 Certification in Myanmar. However, ISO 13485 Certification in Myanmar’s additional stringent risk management procedures provide medical device manufacturers with even greater control over product quality. This level of supervision ensures patient safety, hospital compliance, and the delivery of quality care.
How does a company obtain ISO 13485 Certification in Myanmar certification?
When a manufacturer voluntarily instals an ISO 13485, certification begins. This consists of:
- Required measures
- Design and development planning, review, and validation
- Product and procedure testing
- Device history records and Device history files
- Supply chain monitoring
Documentation is the most crucial aspect of the QMS. Beginning with design planning, producers must document every process and quality control checkpoint.
An independent certifying organization or registrar visits the facility and audits all QMS documentation and processes when the QMS is established. Once the registrar verifies that the QMS satisfies all ISO 13485 Certification in Myanmar standards, an ISO 13485 certificate is issued. To maintain certification, the company must pass audits every three years.
What is the significance of ISO 13485 Certification in Myanmar certification for health systems?
The partnership of a hospital’s buying agents with an ISO 13485 -certified third-party manufacturer provides peace of mind. It implies that the partner intends to stand by the health system in the event of product failure and assures a high level of quality.
Choosing a company that adheres to ISO 13485 Certification in Myanmar standards affects the bottom line. Elite’s products, such as the rear assembly case for Alaris 8100, are typically 30 per cent less expensive than OEM replacement components. This can significantly increase ROI without compromising performance or safety.
How does Factocert help you obtain ISO 13485 Certification in Myanmar?
Factocert provides consultations that provide ISO 13485 Certification in Myanmar and other cities like Yangon, Mandalay, Naypyitaw, Bago, Mawlamyine and other towns with consultation, implementation, documentation, Certification, audit, and other related services across the world at affordable cost.