ISO 13485 Certification Services in Shakarpur, Delhi

Benefits of implementing iso 13485:2016 certification ensure compliance with the requirements of the standard and more streamline your processes, increasing efficiency resulting in significant time and cost savings gain a competitive edge with our independent, globally recognized third party certification benefit from using a single source for all your testing and certification needs take advantage of our wealth of international experience, expertise and global presence in the medical devices market. iso 13485 is an international standard, published in 2003, that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector.

The ISO13485 is a quality system standard for organizations that design, develop, produce or service medical devices. It is intended to promote harmonization in the medical device industry and set a basis for quality system regulations worldwide. All requirements of ISO13485 are specific to organizations providing medical devices, regardless of the type or size of the organization. The certification of a quality management system, specifically for medical devices to ISO13485 proves advantageous, and in many cases essential, for medical companies which export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry. An ISO13485 compliant management system adopt a risk management approach which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization. Adopting this standard is beneficial to the organization in many ways : It demonstrates the manufacturer's ability to supply medical devices and related services that are compliant with all regulatory requirements.Assures the customers that the product complies with all relevant product and service-oriented technical standards and regulations.Emphasizes the cleanliness and sterility in the production area, which in turn increases efficiency and enhances safety at the workplace.Organization establishes for risk management throughout the product realization.

Our ISO 13485:2003 Certification is a quality management system that helps a business to produce or supply medical related devices and services while taking care of the health problems. The key objective here is to facilitate the conformance to medical device regulatory requirements for quality assurance. This quality management system inherits some of the particular requirements of medical devices and excludes some requirements that belong to ISO 9001 as they are not appropriate in the medical industry. ISO 13485 Medical Device Certification specifies equipments a Quality Management system which an Organization needs to demonstrate ability. Though Some of medical devices excludes the requirements of ISO 9001 Regularity.

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