Manufacturing Quality Engineering

Regulatory compliance is just one reason for quality assurance—patient satisfaction also depends on it. Our manufacturing quality engineers have decades of experience with optimizing processes to ensure quality. With RQM+ on your team, quality will be embedded within sustainable manufacturing processes when they are developed or updated, so you are set up for ongoing success.

Our seasoned team has the expertise to analyze data, batch records, objective evidence, control charts, customer complaints, and audit reports. We can create and execute your master validation plan or specific process validation protocols. When nonconforming lots do arise, we will work closely with your internal teams to determine and eliminate the root cause while protecting product integrity and production timelines.

EU MDR and IVDR requirements extend both to new products and those that are already in production. If manufacturing quality procedures and documentation for your legacy products aren’t sufficient for EU MDR and IVDR, we can help you with strategic planning and creation of the required manufacturing documentation to support your submissions. We know you are busy getting products out the door, so let us fill the gaps.

Setting up a new manufacturing facility requires aligning multiple systems, processes, technology, and people. This includes quality planning, validation, registration with regulatory authorities, inventory management, and project management of all activities. The seasoned professionals on our team have extensive experience with site transfers and can guide your team through all of the necessary steps, while navigating the sensitivities associated with a transfer.