COURSE OUTLINE
ISO 13485:2016 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services. Medical Devices are products designed to cope with disease, treat injuries, investigate and augment human functions and they also are made up of a host of other apparatuses and appliances.
The medical device quality system standard ISO 13485:2016 replaced previous ISO 13485:2003 standard after a three year transition ending.
Purpose of ISO 13485:2016
A successful implementation will demonstrate a company’s ability to supply medical devices and related services to customers that comply with regulatory requirements. ISO 13485 is not just product focused, but it focuses instead on the processes used to develop medical devices. Keep in mind that you also need to comply with all relevant products and service oriented technical standards and regulations in this area of expertise.
Who Should Attend
Managers, Executives, Supervisors of various departments: Quality Assurance, Production, Regulatory Affairs, Laboratory, Logistics, Purchasing, Management Representatives, Inspectors and Internal Auditors should attend this seminar.
Seminar Goals
• Understanding process validation, its benefits, and phases of validation.
• Applying process validation in the applicable processes and process validation decision.
• Conducting process validation, preparation of validation protocol and validation report.
• Understanding revalidation, its relation to change control