Quality Management Systems

Right-sized solutions that add value to your business

“I always find RQM+ to be extremely organized and professional. Their subject matter expertise has truly been helpful for us to resolve our non-conformities. Their partnership has truly been valuable and integral to our MDD re-cert efforts.”
– Director, Quality Assurance

Proven and Best Practices for Developing and Remediating Quality Systems

RQM+ uses a customized and business-balanced approach to develop quality systems that align with your organizational goals, from a detailed gap analysis to an implementation of a new regulation across an entire quality system. Furthermore, our dedicated global audit team has you covered, from internal and supplier audits to mock notified body and FDA inspections.

From new product development to post-market surveillance, we have your right-sized QMS solutions.

01 Worldwide Quality Management Solutions
02 Implement New Quality Systems
03 Optimize Existing Quality Systems
04 Remediation for Audit Findings and Warning Letters
05 Compliance with New Regulations
06 Acquisition Integration

Our global team has experience developing and optimizing quality systems that comply with ISO 13485:2016, FDA QSR, EU MDR, EU IVDR, MDSAP, and more. With certified and seasoned auditors on staff to provide on-site and remote audits, our team can identify and correct potential compliance issues before you get audited.

There is no one-size-fits-all quality solution for medical devices and IVDs. Our dedicated team will work with you to develop practical, right-sized policies and procedures for your team to follow. As an extension of your business, we develop your quality systems as if they are our own.

Whether your procedures are too cumbersome to follow or you just need to streamline your process, RQM+ is here with solutions. We’ll identify areas for improvement, map out effective processes and procedures to ensure compliance, and provide the necessary resources for implementation and training.

When an external audit results in nonconformities or a warning letter, you do not always have the internal resources to quickly and effectively respond. Our seasoned team of experts will support you with strategy, negotiation tactics, and leadership of remediation efforts.

The ever-changing regulatory landscape can leave manufacturers with many questions on interpretation and industry calibration. Our seasoned experts will conduct a gap assessment of the current state of your systems to determine the areas requiring compliance to the new regulations. With our unrivaled collective knowledge, RQM+ brings answers and best practice solutions.

Integrating an acquired company with new product lines into your business comes with a lot of moving parts, including updating quality systems. RQM+ understands how it all fits together. We provide support with remediation of any acquired compliance issues, in addition to quality planning for both short-term harmonization and long-term full QMS integration.

Learn more about Acquisition Integration

Subject Matter Expert Support

Supplement your quality team with our experienced resources for specific projects or tasks on a short- or long-term basis.

Technical Management

You stay in control of your quality systems, and we provide technical leadership to make improvements and execute specific tasks.

Project Management

We’ll handle every aspect of your quality systems, from developing strategy and policies to implementing processes, templates, and software.

We partner with you to provide transformative quality solutions that go beyond quickly filling a gap to building in-house skills and capabilities.

Learn more about the RQM+ approach

We aim to be an extension of your business, always focusing on your business objectives.

Audits and Inspections

Your team can’t always keep up with required audits and inspections, but RQM+ has your back. Our dedicated global team of certified and seasoned auditors will perform internal, supplier, and economic operator audits, as well as mock FDA, EU MDR, and IVDR audits to ensure you're prepared.

Learn more about Audits and Inspections

Quality System Regulations and Standards

Evolving quality system regulations and standards require you to constantly stay informed. RQM+ can do it for you with regulatory intelligence and best practices for keeping products and documentation up to date, so you stay compliant with all applicable regulations. Benefit from our collective knowledge and commitment to continually learn from external sources and each other.

Learn more about Quality System Regulations and Standards

Corrective and Preventive Action

Corrective and Preventive Action (CAPA) is a quality management system requirement, but it’s not uncommon for manufacturers to fall behind in handling CAPAs or for their CAPA system to be ineffective. A CAPA doesn't have to inspire dread; if done right, it's a great process for improving your business. Our team creates a better CAPA process for you, and we manage your CAPAs so you meet your plans and schedules.

Updating or creating quality management systems is an onerous task that often requires help from a talented and experienced team. RQM+ has the expertise to provide support at every level and deliver transformative QMS solutions.

Innovative Approach
Business-balanced solutions ensure practical and right-sized quality systems that support organizational goals.

Industry Leadership
Former regulatory and notified body leadership gives valuable insights into auditor expectations.

Strategic Direction
We think beyond quality systems to add value and transform core business methodologies.

Explore our Knowledge Center

Explore Quality Management Systems by Region

US
EU
Global

Quality Management Systems in the US

From developing quality systems that comply with the QSR and ISO 13485:2016, to providing FDA inspection readiness and support, RQM+ acts as an extension of your business. With former FDA regulators and those who have worked closely with them, we know what auditors look for—and how they think. We help minimize audit findings and warning letters related to quality system issues.

Case Study

When CAPA Needs a Corrective Action: A CAPA Remediation Case Study

Case Study

Introducing Our First In A Series of New R&Q Case Studies: Design History File Remediation

Case Study

Introducing Our First In A Series of New R&Q Case Studies: Design History File Remediation

Quality Management Systems in the EU

Quality system requirements have changed dramatically with the introduction of MDR and IVDR. RQM+ has been involved from the beginning, providing quality management system solutions that allow our clients to successfully transition products and stay compliant. Having former notified body leadership and those who have worked closely with them on the team, along with deep industry connections, keeps our quality system experts abreast of the latest focus areas and trends. It also makes our mock audits extremely effective.

Blog

ISO 14971: 2019: X Key Changes from ISO 14971: 2007

Blog

The Medical Device Single Audit Program (MDSAP): Everything You Need to Know

RQM+_Device_Love_Live_28_Recorded-min-New Branding

RQM+ Live! #28

Overcoming Challenges with Integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDR

Global Quality Management Systems

Quality system requirements are always changing regardless of where you are in the world. Our expert consultants are prepared to support you and include certified and seasoned auditors, including MDSAP auditors. Services may include QMS development and/or third party audits, including economic operators.

RQM+ Live! #21

Avoid Audit Findings! Collecting Relevant Data for PMCF Surveys

Webinar

MDSAP: What is it? Is it for me? How will I get it done? [Webinar]

RQM+ Live! #4

Best Practices for Easing the Burden of a Medical Device Remediation Program

FAQs About Quality Management Systems

Why should I build a quality system backwards?

Most companies try to build a smooth running process and then add record keeping at the end. This is why everyone thinks quality adds cost. You should make a list of required records at the start, then build your systems to create them. Remember, when you go to defend your QMS, the only thing you have are those records, so they need to be good.

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PFAS White Paper

Quality Management Systems

Right-sized solutions that add value to your business