Impressive and quality design of the product is vital in the manufacturing of the medical devices in the company. You should always comply with the regulatory requirements in case of product safety as well as risk control. The important element in a device manufacturing is a flawed product which will be a result to become a cause of death of patients or putting in danger. ISO 13485:2016 is the composition of precise directives in various aspects of the product development phase.
GQS focuses on safety measures, regulatory requirements, cost studies, and risk control techniques. During the product development phase, we assist organizations in identifying their goals, a project timeline and the allocation of resources as well. All these elements will ensure your medical device has been ISO 13485 verified according to the various international standards.
We at GQS always help clients of countries such as; Cambodia, South Korea, Singapore, Malaysia, the Philippines, Indonesia, Myanmar, Vietnam, etc in making an absolute definition of using of inputs, product features along with the usability requirements. GQS is always curious to help clients for ISO 13485 Certification, ISO 13485 Consultant, and ISO 13485 Consultancy. You can simply send us the email on; [email protected], we’ll quickly respond to you.