Medical Device Quality System Development
Quality Management Systems
A well thought out and implemented Quality Management System (QMS) provides the overarching structure for operating your medical device business in an efficient and compliant way.
QA Consulting has worked with approximately 50 medical device manufacturers to write and implement Standard Operating Procedures (SOPs) for their quality management systems.
We take great pride in that each of these companies has successfully completed FDA inspections and notified body audits without the issuance of a single Warning Letter or Major Nonconformance.
Development of Standard Operation Procedures (SOPs)
The foundation of a successful Quality Management System is a series of thoughtfully developed SOPs that set the stage for how a company should operate.
For medical device manufacturers just starting out who lack the expertise and experience to write company SOPs, their options are typically to work with consultants like ours to generate customized procedures, or to purchase a suite of off-the-shelf templated documents.
The issue with the latter option is that the templates have often been developed with larger companies in mind and are too complex for a startup organization to follow.
Creating a QMS that is intentionally tailored to your company’s needs will save time and money in the long run.