ISO 13485 Medical devices represents Quality management system and Requirements for managing Quality assurance in Medical device manufacturing, distribution and service organisations as International Organization Standardization (ISO).
It speaks to the necessities for a quality administration system for the structure and review of production of clinical gadgets.
ISO 13485 adapts the ISO 9000 based model for regulating the medical device manufacturing, service and distribution. While ISO 13485 requires just that the confirmed association exhibit the quality framework is successfully actualized and maintained.
Who can achieve ISO 13485 ?
The ISO 13485 certification is a proof of Quality Management System consistence to the standard for organizations engaged with the Medical Device industry. This methodology is just not trailed by Medical Device regulators but also accredited ISO 13485 certification body. Additionally the supply chain such as Subcontractors, Suppliers, Authorized Representatives also should comply to the requirements.
Why you should get certified to ISO 13485?
ISO 13485 is voluntary certification process for medical devices, where most of the quality management system requirements and demonstrate compliance to medical devices requirements. Apart from harmonizing regulatory requirements, there are various other great benefits such as meeting the expectation of the customers, increase efficiency.
ISO 13485 management system is the best methodology that organizations need to get ready for a universal market. Being ISO 13485 certified confides to partners and interested parties with the certainty that the association has invested all the confidence to adjust to the medical equipment management standard. This enhances the confidence of the customers, quality and speed of service.
The basic objective of the ISO 13485 certification is to promote & comply medical device regulatory demands. ISO 13485 also promotes better understanding of the process for the effective quality management system.
Moreover, ISO 13485 will also improve the relationship with interested parties.
Benefits Of achieving Certification Of 13485 ?
ISO 13485 Certification can assist you with improved product quality and reducing the vulnerabilities based on the Risk assessment carried out by ISO 13485 experts from GQS
It also helps meet process necessities and client requirements.
- Enhancement in efficiency and reduced expenses
- Enhanced access to markets worldwide with 13485 certifications
- Carry out Design changes based on market inputs and changes in medical technology.
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