A Risk-Balanced Approach to Design and Manufacturing Quality Engineering
Our engineers and scientists are committed to helping you get safe and effective products to market while balancing business goals. With seasoned design quality engineers and risk management experts, your new product development teams will feel supported and never stifled. Our manufacturing quality engineers will bring solutions to your biggest challenges.


From new product development to manufacturing site transfer, RQM+ has you covered.

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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.

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Subject Matter Expert Support

RQM+ sets the bar high, with a team of only the strongest quality engineers to support a project of any size and complexity.

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Technical Leadership

We provide strategic and technical leadership for the biggest challenges throughout the product life cycle.

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Project Management

For large programs, RQM+ project managers work with you to define the project scope, develop the plan and schedule, and lead the team of combined resources to ensure the project is delivered with efficiency and success.

Our dedicated resources fully integrate into your product development teams to become an extension of your business.

Learn more about the RQM+ approach


We are a strategic partner that provides business value, with quality engineering expertise throughout the product life cycle and a deep understanding of your goals.


Design Quality Engineering

We have participated in product development teams across all device types and in every major market. When we join your team, we add our world-class technical expertise and our decades of experience with regulatory agencies and notified bodies.

Learn more about Design Quality Engineering


EU MDR/IVDR Strategy

Our team has prepared hundreds of technical documentation files, including updates and remediation to all impact areas: risk management, hazardous substances, standards reports, labeling, packaging, and manufacturing processes. With every submitted file and notified body response across our client base, in addition to feedback from our deep industry network, our collective knowledge grows—and you benefit from all of it.

Learn more about our Unrivaled Collective Knowledge


Manufacturing Quality Engineering

RQM+ provides a range of manufacturing quality engineering services, including quality assurance of manufactured products, process improvements, manufacturing site transfer, implementation of MDR/IVDR requirements, and validation of computer systems, packaging, and sterilization.

Learn more about Manufacturing Quality Engineering


We understand devices, and we also understand business. While your internal product development teams are focused on developing the best possible devices, RQM+ assesses risk and makes sure you stay compliant with documentation, testing, and any other activities to keep you audit and regulatory submission ready.

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Risk-Balanced Approach
We understand the big picture and the small details, balancing business goals with regulatory risks.

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Industry Leadership
Former FDA and notified body leadership on staff provide high-value insights into regulator expectations.

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Practical Expertise
Our seasoned engineers have worked with every device type and issue.

Explore Quality Engineering by Region

For the US

Our expert resources integrate into your product development and manufacturing teams, ensuring the safety and effectiveness of your device, producing a comprehensive DHF that meets FDA expectations, and performing effective process validations.

 

For the EU

With the introduction of EU MDR and IVDR, many manufacturers have realized their technical documentation for existing products is not compliant and must be remediated before going through the certification process. We’ll provide a gap analysis to identity where your files are lacking, subject matter experts to guide your team, or full remediation services from strategy to implementation.

Global Quality Engineering

No matter where your devices are developed, manufactured, and sold, we have seasoned experts with the knowledge and expertise to get your safe and effective products to market. We have worked with every type of device and tackled every type of problem, so no matter what challenges you face, RQM+ is here to help.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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