UAE is booming with medical device manufacturers and exporters. There are many organizations in various cities of UAE, such as Sharjah, Dubai, and Abu Dhabi that are part of the supply chain of medical devices- from manufacture to retail. In order to gain a competitive edge, these organizations must eye for ISO 13485 Certification in UAE.
ISO 13485 standard is published by the International Organization for Standardization (ISO) to help the organizations in building quality management systems for medical devices. If you are a medical device manufacturer, distributor or retailer, getting ISO 13485 certification in Dubai, Sharjah, Abu Dhabi or other cities has become easier with KSC Certifications. Read the entire article to understand the common benefits associated with ISO 13485 certification. The medical device manufacturers are required to maintain a balance between meeting the expectations of customers and meeting the necessary regulatory requirements. Therefore, gaining an ISO 13485 certification can be really beneficial to them. In addition to that, it also ensures consistency in the quality and safety of these devices. By way of identifying the potential risks to quality of the medical device, incorporating certain actions to mitigate them, and documentation of the entire process, ISO 13485 Certification ensures the implementation of an effective quality management system for medical devices. The risks associated with medical devices may arise from contamination of equipment or other human errors at the time of handling. ISO 13485 provides a framework for analyzing those threats in order to prevent them from occurring. Resolve the issue once and forever The ISO 13485 certification is based on the requirement of regular management review in your organization. This ensures that the controls that are being implemented are able to deliver the desired results. Preparation of documentation and timely update of the same is extremely important to make the process of management review less burdensome. The decision-makers will be able to measure the effectiveness of applied controls only through reports from internal audits, latest regulatory requirements, and customer feedback. This also helps in the identification and prevention of the occurrence of persistent issues. It gives you a competitive advantage With ISO 13485 becoming a primary requirement to do business, ISO 13485 certification in UAE has found many takers. Many vendors and sub-contractors are required to conform to the specifications of ISO 13485 standard. Therefore, ISO 13485 certification enables you in becoming a key player and a preferred choice in the supply chain of medical devices. The global recognition of this standard opens up the entire international market for your business. ISO 13485 standard gives assurance about the quality and safety of medical devices to your customers, thereby, making you a preferred choice. Reduced product recalls By implementing the standard’s requirements, such as regular monitoring and measurement, and continual improvement, you ensure the quality and safety of your medical devices. This reduces the chances of recalls of your products, which in turn helps in cost savings for your organization. ISO 13485 Certification Makes the Medical Device Companies stronger The innovation and application in medical device sectors should always be coupled with the safety and quality assurances. This is because, it is a very critical industry. In addition to that, the manufacturing units must be capable enough to ramp-up their production in response of any sudden demand spike, such as the one we witnessed during the time of Covid-19 pandemic with respect to ventilators, PPE kits, etc. Moreover, the continual improvement of products and processes that is a part of ISO 13485 certification, contributes to organizational resilience, making them stronger. If you are associated with medical device sector and looking for ISO 13485 certification in UAE, KCS Certifications is here for you. Even if you are a small retailer from Sharjah or have a manufacturing unit at Abu Dhabi, this certification is very beneficial for your business.
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About KCS CertificationKingsmen Consulting Services (KCS) with effect from 02nd July 2014 established in Dubai, UAE, is a Division of “Kingsmen Group”. KCS is one of the pioneers established mainly to cater the Construction and Oil & Gas Sectors to provide Management System Consulting Services under various ISO standards which was gaining popularity and was the need of the hour since the release of ISO 9000 Standards for “Quality Management Systems” in 1987 and is today known among the top Consulting companies in the region. Currently KCS is into the Management Systems Consultancy of QMS (ISO 9001:2015), EMS (ISO 14001:2015), OH&SMS (ISO 45001:2018), FSMS (ISO 22000:2005)/FSSC 22000, EnMS (ISO 50001:2011), ISMS (ISO 27001:2013), IATF 16949 & SMSSC (ISO 28001:2007) and many more. Branching out Kingsmen Group, which is primarily into Sustainability Solutions for Products and Companies including Ex Certifications for Products entering Hazardous Environment like Oil & Gas industries has become one of the lead business activities within the Group. With a humble beginning having 03 Consultants, today we boast at least 20 Consultants on board with strong Implementation Projects across various ISO Standards, still looking to expand beyond boundaries in the Middle-East with references already existing in Oman, Saudi Arabia, Qatar, Bahrain, apart from the UAE. ArchivesCategories |