Medical device manufacturers must operate in an environment of complex global regulations. Failure to comply is not an option: A single misstep can result in enormous fines, company sanctions or worst of all—adverse patient events—putting the company’s very existence at risk.
To prevent problems, medical device companies take great care to comply with regulations such as ISO 13485, 21 CFR Part 11, CGMP and other regulations and standards. But regulatory complexity exceeds the ability of spreadsheets and other manual systems to ensure compliance. Medical device manufacturers need an EQMS designed to manage the requirements of the industry.
Medical device organizations need an easy to use, quick to implement and comprehensive automated EQMS like the CEBOS offering.
Medical Device Industry Commitment and Vision
CEBOS has been supporting the quality and compliance needs of the medical device manufacturing industry since the company was founded. We have a complete team of experienced medical device industry and compliance experts. In addition to working with customer input, we work with industry organizations like MDMA, ADVAMED and RAPS to ensure we know about upcoming changes and issues.
Continuous improvement and constant innovation are essential to providing the best products for our medical device industry customers.
Companies can’t operate in the medical device industry without proving they comply with standards and regulations. CEBOS designed its EQMS to meet the needs of medical device manufacturers to ensure fast and complete quality recording to simplify audits and validations.
Automation eliminates the need for manual processes that require extra steps, phone calls or offline actions to complete quality reporting, helping put an end to errors or omissions that other systems can’t prevent.
CEBOS EQMS seamlessly shares data across business processes to eliminate redundancies. For example, Document Control spans Project Management for Commercialization and other business projects, Gauge Calibration, SPC, Training, Inspection Plans, Auditing, CAPA, and other aspects of your business.