SOP Writing and Editing 

Are you building out or improving your QMS? ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. To have a successful QMS, you need specific Standard Operating Procedures implemented. 

Need a Standard Operating Procedure (SOP) or Work Instruction written or reviewed? We have the knowledge and expertise in this area as well. No matter if it is a procedure for Regulatory Assessments or Establishment Registrations, we can handle that for you.