Types of Medical Devices Quality Management System Audit

Types of Medical Devices Quality Management System Audit

• Model Control; It is an application made before the certification or interim audit in order to determine whether the enterprise is ready for the audit and to eliminate the deficiencies before the audit.

• GAP Analysis Control; It is an audit to determine whether your current practices are appropriate within the scope of relevant standards, regulations and laws, or to maintain compliance with changing, updated standards and laws. It is also an important process to determine whether it meets the requirements of that country before entering different markets.

• Supplier Audit ; If you are producing in a different company and you want to be sure that your supplier provides this service in accordance with the current/valid Medical Device Regulation and other relevant standards, a critical supplier audit should be performed.