Design and Manufacturing Quality Engineering

RQM+ quality engineers have diverse experience across all device types—electromagnetic, software, sterile disposables, implantable, and more—enabling us to quickly adapt to any situation. Whether we are involved from the start of development or get brought in when challenges arise, we will be there to get your safe and effective products to market and keep them there.

RQM+ design quality engineers (DQEs) bring broad expertise across device types and clinical specialties. We recruit only DQEs with the ability to analyze risks and provide you with multiple pathways. Our DQEs integrate into your product development teams, filling every need. This includes reviewing design documents, creating risk-management files, supporting design reviews, and assessing defects and software anomalies. Our clients often give us the most complicated and innovative devices in their portfolio to support.

Safety risk management requirements and enforcement have significantly increased with the MDR, IVDR, and ISO 14971:2019. Manufacturers are especially struggling to both bring legacy products into compliance in time for MDR/IVDR certification and maintain their risk files. Trust our experts to update your procedures with best practices, integrate risk with clinical and post-market surveillance, and remediate your risk files to meet notified body expectations - today and in the future.

MDR and IVDR implementation will certainly highlight gaps and weaknesses in your design history files, labeling, and manufacturing processes, especially for legacy devices that have not been audited in many years. Our detailed, automated gap analysis tools enable efficient analysis and deliver results organized by function for ease of planning. Our expert implementers will then facilitate filling gaps with your teams, or provide tiger team support of the remediation to enable you to continue with daily operations.

Whether you are expanding or integrating a new facility after an acquisition, manufacturing site transfer requires broad knowledge and skill sets across quality, regulatory, and project management. RQM+ can supplement or lead your team to a successful site transfer that stays on time and on budget.

Small changes in manufacturing processes can have major impacts—even a minor adjustment can significantly impact the cost of quality. Our global team will travel to your facility to assess and optimize your current manufacturing practices, ensuring they are not only compliant, but also as efficient and cost-effective as possible.