A step-by-step electronic quality management system (eQMS) with experienced QMS consultants who partner with your team to have your company compliant with the FDA and Notified Bodies.
A step-by-step electronic quality management system (eQMS) with experienced QMS consultants who partner with your team to have your company compliant with the FDA and Notified Bodies.
Don't wait 6-8 months, let's talk about how we can get you up and running in 6-8 weeks!
With IntelaSolve eQMS, you pay once and get the complete system. No consultants clocking endless billable hours!
IntelaSolve eQMS is the easiest, quickest, most affordable, and thorough system you’ll find anywhere to accelerate your business performance while meeting your compliance obligations.
It does not matter what stage your company is in. Whether you are in the early stage and don't have a product on market, in the clinical stage and conducting clinical trials, in the submission stage and working with the FDA on Clearance or Approval of your device(s), or in the commercialization stage and have product(s) already in market; IntelaSolve is a robust eQMS system that can be customized for your specific needs.
LEARN MORE
Most companies that opt for a paper-based system do so because they’ve experienced sticker-shock at the price of most eQMS platforms out there today. Paper-based systems, however, can be just as expensive because they require a great deal of more people to develop and maintain. IntelaSolve brings you a fully configured solution tailored to your specific business & compliance needs. We validate and deploy it for you in eight weeks or less. All for about ½ the cost it would take to deploy any other eQMS or implement a paper based QMS.
SCHEDULE A FREE DEMO
Have you received a regulatory notice or a major finding during your ISO audit?
We can help you respond and quickly formulate corrective actions to prevent further disruption to your business.
Leverage our decades of experience by letting us help you confidently prepare for your inspection or audit.
Get Started
We can help you navigate the maze of regulations and avoid common mistakes. Need a Regulatory Strategy? We can help. Need your first Quality Management System? Ask us about IntelaSolve eQMS.
Contact Us
"Without a doubt, Melita and her group were the best consultants I have had the pleasure of working with during 30 + years of Medical Device/Combination Products design, manufacturing, sterilization and distribution. I consider Melita to be an expert on Quality Management Systems as well as the Regulations and Standards that govern it. Her auditing resulted in clear and concise opportunities for improvement and her group’s software development/validation/delivery and Service are second to none."
"I have worked with MBCA for seven years and have the highest degree of respect for Melita and her abilities. She possesses a deep knowledge of medical device requirements and the regulatory climate that is not universal among consultants. She understands the intent of the regulations and readily shares this with her clients to teach them and improve their compliance. She not only appreciates the interrelationship of the QMS processes on a philosophical level but has the in-depth of knowledge to translate them into a quality management system that meets your company’s unique needs.
"I have brought MBCA in to work with us on our Quality System on several occasions because I like Melita’s streamlined approach to Quality. She and her team have breadth and depth of experience across a variety of medical device businesses that provides me with confidence that she is keeping us at the forefront of best practice. I recommend MBCA for anyone looking for consulting services in domestic and international Medical Device Quality."
