ISO 13485 represents the requirements for a comprehensive management system for the design and manufacture of Medical Devices (Also called as MDQMS – Medical Devices Quality Management System). ISO 13485 focuses on assuring that organization fulfill their regulatory and legal obligations. ISO 13485 reviews and product certification for medical device manufacturers without compulsory obligation. Our ISO 13485 certification pursues equal protection of your organization in administering the requirements and legal obligation as well as protection of consumers.

To achieve and to grant certification through the rigorous regulation through ISO 13485 helps your organization in fulfilling the specific requirements and expectations of managing medical devices. Medical devices, whether importer, distributor, producer or otherwise operating within the medical devices supply chain worldwide is a regulated sector. In addition, to help administer operations, processes, procedures and records and that equally provide objective evidence to customers and regulators on your commitment to consumers and quality of medical device and market acceptance.

ISO 13485 follows the process approach that ISO 9001:2008 establishes and compliance take the form of updates. ISO 13485 provides a basis to effectively manage legal and regulatory requirements compliance as these are invoke by the USA FDA and equally EU CE medical device directives and equally other countries with due care.

ISO 13485 requires that we monitor organizations through on site assessment of an organization’s regulatory requirements and legal obligation. Benchmarking of ISO 13485 provides recommendation and thus granting a certificate confirms that the organization’s management system meet its regulatory requirement and legal obligations with due care. This means that certification of a management systems carries impartiality and competence to fulfill accreditation requirement whether regulatory requirement legal obligation or contractual agreement with due care.

This is a guidance to help producers with responsibility to design, develop and manufacture medical devices. From identification to control of risks as integral part from design through delivery medical devices for use. ISO 14971 provides as structured process to identify, assess, categorize and control risks. Risks analysis need to be part of design validation. The Risk Management done for devices for ISO 13485 (MDQMS) is done as per the International Standard ISO 14971 which is included in the implementation of ISO 13485