3.7. External Assessments
Evaluations conducted by independent organizations or regulatory bodies to verify that the manufacturing processes, quality systems, and product outputs meet established standards and regulatory requirements, ensuring continued compliance and market approval.
FDA / FDB Inspections
Notified Body Audits
Customer Audits
Regulatory inspections by the relevant authorities to ensure compliance with applicable regulations.
Assessments by a designated Notified Body to verify compliance with the requirements for CE marking.
Evaluations conducted by customers to assess the medical device manufacturer's quality system and manufacturing capabilities.