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Quality Management

With our decades of experience and success in developing, implementing, and maintaining Quality Management Systems, we can support you through a full QMS implementation or help with remediation efforts for your existing QMS. During your complimentary consult, be sure to ask about IntelaSolve, our full eQMS deployment for start-up and small companies.

Quality Management Systems (QMS)

IntelaSolve eQMS

QMS Remediation

Internal & Supplier Audits

FDA 483, Warning Letter, Consent Decree

Interim Quality Professionals

Training & Education

Merger & Acquisition

Quality Management Systems (QMS)

With decades of experience, our expert team can take your business to the next level. At MBCA, we combine our insights and skills to transform your quality system into a high performing network focused on excellence and efficiency. We’re proud to help shape and improve how our clients perceive and manage their compliance risks and, in turn, achieve their business goals efficiently and effectively.

We provide innovative quality management system solutions that improve performance, eliminate inefficiencies, and increase compliance.  We have a lean and practical approach that streamlines your compliance activities to what is necessary but also meaningful to your business.  Whether you need to re-engineer one section of your quality management system or need a complete reset, let us show you how to maximize your investment to ensure long-term success.

IntelaSolve eQMS

Does your start up need its first ever Quality Management System before you can put your device on the market?  Do you have a tight timeline? Does your small company need a QMS reset because you grew too fast and didn’t take the time to establish an effective and efficient QMS the first time around?  IntelaSolve can be your answer.  Through technology, amazing tools, and a lot of innovation our team establishes your full Quality Management System in less than 8 weeks!

Your custom eQMS will be complete with procedures tailored to your business, built-in training management, custom electronic workflows to handle your unique QMS processes, and complete end-to-end real-time records that compile from the workflows.  We will configure it, validate it, and deploy it in record time so you can get back to the business of delivering innovative devices that make the world a better place.  We can even help you manage it for as long as you need it.  Just ask about our IntelaSolve post-launch service packages. LEARN MORE

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QMS Remediation

Have you spent years developing a device just to learn that the FDA puts it on hold because your Design History File (DHF) does not contain enough evidence to prove the product was designed correctly?  Our team can help reconstruct your design documents and create a compliant DHF and ensure that you have a compliant development process, so it doesn’t happen again. Whether it is software or hardware, internet-connected wearable technology, surgical instruments, or an active implantable device, our team has the expertise to get you back on track and on the market.

Are you facing penalties from the FDA or your Notified Body because they found significant compliance gaps when they inspected or audited your Quality Management System?  Our highly experienced remediation teams will help you uncover the root cause(s) of these issues and work side-by-side with you to bring your systems into compliance and to ensure you can efficiently maintain the systems for the long-term.

Internal & Supplier Audits

Auditing With our broad range of global auditing expertise, we are here to support whatever auditing needs you may have. Looking for Mock FDA Inspections or an MDSAP readiness Assessment, or an EU MDR Assessment? Do you need routine Internal Audit support or help performing audits of your global suppliers? We provide cost effective alternatives to hiring an army of FTEs to support your supply chain.  ​

Ask us how we can put your supply chain qualification and monitoring activities on autopilot and, in turn, drastically reduce your costs and compliance risks in this heavily monitored area.

Our full staff of qualified auditors can support virtual, on-site, or hybrid audits in a turnkey, efficient, and cost-effective way, for as long as you need us.

FDA 483, Warning Letter, Consent Decree

Receiving FDA 483 observations or a Warning letter can be a distressing experience.  Consent Decrees are even more unsettling.  Don’t try to go it alone.

FDA 483 observations are never fun to receive but, if answered and corrected adequately, you can avoid the more serious FDA Warning Letter or Consent Decrees that can come next.  When a manufacturer is found to be in serious violation of federal regulations, it requires prompt, adequate responses, and follow-through with effective corrective actions.

Regardless of which scenario you find yourself in, seeking assistance from an experienced and seasoned group of regulatory compliance professionals before you go it alone can drastically improve the situation and help your organization get back on track quickly.

Interim Quality Professionals

Do you need an interim Head of Quality or a Management Representative while you seek to find the right long-term fit for your organization?  Do you need Quality Engineers to support manufacturing or design?  Regardless of whether it is a seasoned executive or a innovative engineer, we have the right-sized professional to support you … usually at the same or lower cost of an FTE.

Training & Education

Looking to develop your resources on regulations, standards, quality management, design control, CAPA, or complaint handling but not sure where to turn?  Need ongoing auditor training to stay on top of the rapidly changing global regulatory landscape?

Our trainers are globally recognized leaders in their fields and provide expert education and real-world expertise.  We go beyond the textbooks and PowerPoint slides and bring real life experience into the classrooms to achieve maximum adult learning.

Merger & Acquisition

Is your company in M&A negotiations?  Don’t forget about the Quality Systems!  When companies merge or are acquired, Quality Systems are impacted.  It can cause major disruptions in your ongoing operations, delays in delivering products on time, and significant compliance issues that can lead to regulatory actions.  These disruptions can directly hit your bottom line and your reputation.  We are experts in planning for quality system mergers and acquisitions.  We will work with your unique situation and deploy strategies that will minimize the disruptions and ensure the transition is as seamless as possible.

Need Immediate Assistance? 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. Get Assistance

Upcoming Inspection or Audit? Leverage our decades of experience by letting us help you confidently prepare for your inspection or audit. Get Started

Taking your first product to market?

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

Contact our experts How can we help?

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Need Immediate Assistance?

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.

Get assistance ›

Upcoming Inspection or Audit?

Leverage our decades of experience by letting us help you confidently prepare for your inspection or audit.

Get started ›

Taking your first product to market?

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 ›

How can we help?

Tell us what you are working on and we will point you at the fastest route to compliance.

Schedule a free consultation