Quality System Services

MAE Group quality professionals make sure that your company and devices are in compliance to applicable quality system standards and regulations. A compliant quality management system is the backbone of any company and crucial in ultimately gaining regulatory clearance or approval. Maintaining, through objective evidence, good standing with the FDA and other global agencies is key to navigating through post-market surveillance audits. 

MAE Group can act as your quality partner while your company grows with your new and unique medical device. We can create your quality system for you, from the ground up in a phased approach that matches your company life cycle. When it’s time, we’ll train and teach your staff to take over.

MAE Group conducted a gap assessment of our Regulatory and Quality Systems and Processes.   It was thorough and accurate.  You then provided remediation recommendations as to how to move Bergen into a strong and compliant position.  Your team did an excellent job as they worked on the remediation effort.

Mark E. Kolb, CEO Bergen Medical Products

Our team specializes in designing and implementing FDA and/or ISO compliant quality system to both medical device and pharmaceutical regulations.

You’ll have experts managing quality assurance activities during the design process from back-of-envelope idea through post-market surveillance. MAE Group offers extensive knowledge in quality assurance review and/or auditing of vendors and their quality systems, products, and design and production environments.

The Quality Team serves you through verification and validation of products and production processes, including software (for quality system and for device functions), bulk formulation processes, sterile and non-sterile packaging.

FDA warning letters or any findings can put undue stress on your business growth objectives. Our knowledgeable team offers you the assistance you need for remediation of FDA 483 findings, warning letters, or any other adverse findings. We’re on your team through the whole process. Learn more.

Recently we had an FDA inspection.  Your team participated and supported Bergen through the entire process. Your expertise and frankly your experience with this proved to be a great benefit to Bergen.

Mark E. Kolb, CEO Bergen Medical Products
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