Medical Device Compliance Solutions for Your Business
MBC & Affiliates, LLC
Medical Device Training, medical device regulatory compliance, 483 Observation Help,
Medical Device Consultants serving Class I, II, and III Medical Device Companies, the In Vitro Diagnostics market, and Medical Device Data Systems around the world.
Our model for success:
Long term relationships with our clients
Consistent, practical compliance solutions that work!
Creating high performing Quality Management Systems
Reduction of regulatory compliance risk
Improve company’s standing with the FDA
We implement comprehensive Quality Management System Requirements that are scaled to fit your individual business needs. Our unique approach blends assessment, planning, remediation, and implementation tools so you get the best possible outcome not only from a compliance perspective but also from a performance perspective.
We provide complete gap analysis assessment reports including detailed recommendations for system improvement, methods to reduce regulatory risk, and ways to increase business efficiency based on industry standard practices.
With our full suite of Supply Chain Quality Management and Supplier Quality Outsourced Solutions, you will simultaneously reduce your regulatory risk in this area and increase your productivity!
Have You Received a Warning Letter from the FDA? Has the FDA Deemed Your Response “Not Adequate?” Just one quick glance at the recent Warning Letters issued by the FDA and you will see an all too common response from the FDA … “We reviewed your firm’s response and concluded that it is not adequate.” If this has happened to you, we can help! We can help you develop proven responses that will give you time to implement the short and long term solutions the FDA demands. There is a right and a wrong way to respond to FDA enforcement actions. Our FDA regulatory compliance consulting experts will help you formulate the correct response for your situation.
MBCA provides comprehensive regulatory affairs consulting services for companies attempting to get their medical device through the regulatory process.
We have the real-world experience and expertise to determine what class your device fits into, what type of regulatory submissions are required for your class of device, what predicate devices are most appropriate for your device, and how much time and money it will cost you before you can start making a profit.
MBCA offers custom training courses and a public course that is the only medical device auditor course to cover ALL major regulations & Standards for Medical Devices. It is now updated to include the new Brazilian Regulations! One course prepares you to perform Medical Device Quality audits in accordance with ALL major regulations and standards with hands-on exercises and a mock audit.
483 Observation Help
, medical device regulatory compliance
, Medical Device Remediation
, Medical Device Training