Standard Operating Procedures for Medical Devices — Project Management Must-Haves
Medical Device Standard Operating Procedures (SOPs)
The cornerstone of successful Quality Management Systems (QMS) are deliberately prepared standard operating procedures (SOPs). Standard operating procedures for medical devices outline recurring operations or processes and help to maintain quality and consistency. To remain compliant with regulatory agencies including the Federal Drug Administration (FDA) and International Organization for Standardization (ISO), medical device companies need to develop SOPs that outline a variety of operations, such as those for manufacturing, risk management, and training.
If you need assistance determining when and how to establish SOPs for your medical device company, contact QA Consulting today to get started.