ISO 9001:2015 and ISO 13485 are acronyms used in the medical equipment industry. These are international medical device standards that make it possible for companies to supply equipment which are reliable and safe for healthcare professionals. ISO 13485 revolves around establishing, implementing and demonstrating particular procedures, policies and processes. It aims at mitigating the risk. Thus, the primary objective is to facilitate appropriate medical device regulatory requirements so as to bring in the quality management system. ISO 9001, on the other hand, focuses on consistent improvement and also the best use of customer feedback.
Medical Equipment Only From An ISO-Certified Company – Why?
ISO certification is linked to enhanced quality of the medical profession. Buying equipment from an ISO-Certified company paves the way for a safe medical profession for doctors, surgeons and, even administrators.
- Only an ISO-Certified company has an approved quality policy which its staff strictly adheres to. The policy features the commitment of delivering the product and service of the highest quality.
- ISO certification eliminates possible delays and even obstacles that can arise during processes such as equipments’ production monitoring, inspections of installation, storage, functioning, operation and maintenance processes, etc. As a result, many countries in the world follow stringent regulations that require surgery centers and even hospitals to purchase medical equipments from ISO-Certified providers only.
- ISO-Certified companies make sure to deliver the best customer experience involving faster order processing time, quick technical support, continuous improvement in the functionality of a product, etc.
- As aforementioned, ISO 13485 requires medical equipment companies to focus on risk management. Certified companies do provide evidence that they manage risks right from the time when they start preparing a device. Even the post-delivery phase is taken care of well. Buying medical devices from a company that strictly adheres to risk management policy helps hospitals to reduce liability risks.
- The peace of mind with which hospitals, clinics, etc. work leads to patient’s safety and satisfaction. Doctors, surgeons and other medical staff can make sure that the equipment is designed by a quality-minded service provider and thus enjoy peace of mind.
These are enough reasons to purchase medical equipment only from an ISO-Certified medical device company. With an aim to facilitate better healthcare, Medinnova Systems Pvt. Ltd is an ISO-Certified medical device company, with certificate in ISO 9001-2015, ISO 13485:2016 and IAMERS. We believes in providing products of high-quality and also serving customers with technical and non-technical support that they need with respect to the equipment. Call our Sales Team today on +91 +9925186973 or send us an email at email@example.com to experience the real world of quality assurance.