The FDA governs the requirements for medical device compliance. The scope and breadth of the definition of medical devices continues to expand with new technology being constantly introduced. Medical device companies are one of the fastest growing sectors of business today. The extent of Products and Medical Procedures range from Pediatric devices, Home Health and Consumer devices to Obesity Treatment devices and Life Support Devices. Even Implants, Prosthetics, Dental devices and Cosmetic devices fall under its jurisdiction.
Whether your company is pre or post commercialization, your company is managing your documents related to Safety Communication, Medical Device Reporting, sterilization procedures and employee training. If you are currently doing version tracking manually or using spreadsheets or if you are managing your training records in file folders for each employee in your HR department, ENSUR quality control and DMS system can help you become more efficient while reducing inevitable human error.
Implementing a document control and quality management software application can seem to be a daunting task especially under 21 CFR Part 11 requiring a validated software environment. Working with DocXellent to get your DMS System installed and validated could not be easier. Whether your company policies dictate internal validation or if the required resources aren’t available, DocXellent is there. Working with IT for the complete IQ and having thorough and battle tested OQ Validation scripts make the process a breeze.
If you want to join the many Medical Device industry companies that have made the switch from manual tracking to an automated and integrated DMS system solution, give DocXellent a call to discuss your unique requirements. You’ll be glad you did.