Services


R&Q is proud to announce national certification as a Women’s Business Enterprise!

The designation signals a competitive advantage for R&Q’s FDA-experienced team of more than 80 RA/QA experts as medical device and pharmaceutical companies often look to vary their supplier base with more diversity and/or minority-owned businesses. Read the announcement and statement from Cofounder and President, Maria Fagan.


Regulatory

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We do:

  • Worldwide Regulatory Strategy
  • FDA Clearance and PMA
  • EU Entrance
  • Canadian License and Approval
  • Rest-of-World Support
  • Guidance for Regulation and Standards Changes
  • Acquisition Regulatory Due Diligence
  • UDI Compliance
  • MDD Technical File Clinical Evaluation Reports
  • Combination Products

A forward-thinking strategy.

RAPS-Enterprise-Member-Logo-min.pngR&Q will help you accelerate the device-to-market process anywhere in the world. Your device will get to the people who need it sooner, and we all recognize what a difference that can make. Understanding the most efficient way to get your product to market matters, and making it actually happen matters more. R&Q helps medical device companies of all sizes do this. We work with you - not for you - to determine what solution is best for your needs.

Experience to lean on.

You want to put a safe and effective device on the market and ultimately improve lives - just like we do. R&Q is an industry leader who has worked in every FDA medical device clinical specialty, so you know our high-performing, adaptive team is ready for any task. Class I, Class II, Class III... we've executed on them all. Whether you face domestic or international challenges - or both - R&Q's team is prepared to become an extension of yours to get the job done.

FEATURED CONTENT: Read our Regulatory Strategy and Clinical Evaluation Report case studies.

[fa icon="plus-square"] Need help with UDI?


UDI is more than a quality/regulatory issue, label change, one-time project, and FDA ID system. UDI is a requirement that affects your entire business and product life cycle.

Contact us to discuss how we can develop and implement a strategy to meet your UDI objectives... on time.

UDI_Example_2-min.pngTo meet your UDI needs R&Q offers:

  • Project management
  • Data management
  • Work stream leadership
  • Training
  • Validations
  • Labeling
  • QMS
  • Infrastructure

"After the resignation of the program manager of our largest division, we reached out to R&Q for assistance in implementing UDI. They were able to come in and quickly assess our needs, working seamlessly with all levels of our organization. Not surprisingly, all planned compliance milestones were met."
- Overall UDI Program Manager, $25B Multinational Medical Device Company

 


Quality Systems

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We do:

  • Quality System Development (ISO13485 / QSR / CMDR)
  • Internal Auditing
  • FDA Inspection Preparedness/Assistance
  • Quality System Improvement Projects
  • Acquisition Quality Systems Integration
  • Combination Products

The right system for you.

We never recommend a cookie cutter solution. Each company we work with is different, and our team goes to great lengths to ensure we help implement the right systems for your needs. Whether your quality system needs developed from the ground up or simply needs streamlined, R&Q merges with your existing team to make it happen. We are ISO 9001:2008 certified.

A business-balanced approach.

What does business balanced mean? It means that we understand you have a company to run. You need solutions that not only get your product to market, but get it there faster, and ultimately improve your bottom line. R&Q is ISO9001 certified, and every single service we utilize for clients - and our own employees - is built into a system to ensure satisfaction. After all, if our own business can't continue to move forward, how will yours? R&Q understands what it takes.

CHECK OUT our Quality Management System (QMS) Integration case study.

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The time is now to start your transition to ISO 13485:2016. Certification bodies will have difficulty having enough auditors and long wait times are expected. R&Q’s QMS expert, Mark Swanson, was a member of the ISO working group that revised ISO 13485, so R&Q can supply details on the intent behind the requirements.

READ our 7-Step Gap Analysis Checklist and begin a conversation with us.

 


Design Assurance

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We do:

  • Design Verification and Validation
  • Human Factors/Usability
  • Safety Risk Management
  • Design Quality Assurance
  • Design Quality Engineering (Software, electromechanical, sterile disposables)

Your best device to market.

R&Q helps you ensure your best possible medical device goes to market. This includes verifying your design to ensure it hasn't missed addressing any requirements (we know how difficult this can be) and validating your design as well. Seeing the final device take shape is what it's all about. It's not just an important process to your success, but a beautiful one, and we'll help you every step of the way.

Test and optimize.

R&Q will help you identify device features that should be optimized throughout the entire life cycle of your device. Through human factors testing and usability engineering, we can help improve the usability of your devices to reduce use error, injuries, and product recalls. This includes reducing current control risks and future risks associated with device use.

READ our case study on creating and implementing a compliant usability engineering process.

DOWNLOAD our 10 Tips for Successful Integration of Risk Management and Usability Engineering white paper.

 


Product Quality

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We do:

  • Supplier Quality and Audits
  • Manufacturing Site Transfer
  • Manufacturing Quality
  • Process Validation/Qualification

Your device comes to life.

It's time for your medical device to mature and get ready for prime time. R&Q ensures you are prepared for the gamut of challenges a typical device company will face at this stage: supplier audits, site transfer, manufacturing quality, and process validation/qualification. This doesn't have to be disconcerting, and because of the experience and leadership R&Q will bring to your company, it's almost always not.

Exceed expectations.

Your medical device must obviously meet expectations... but can it exceed them? R&Q strives to delight our clients at each and every turn. By doing that, we help ensure that the users of the medical device are delighted as well. Maintain product quality - whether physical, electrical, functional, or visual appearance - and success for the medical device will follow.

TAKE A LOOK at our Process Validation case study.

 


Post-Market Surveillance

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We do:

  • FDA 483s
  • Warning Letters
  • Consent Decrees
  • Remediation Support (see below)
  • CAPA and Complaint Monitoring/Leadership
  • Safety Risk Monitoring
  • Recall Decisions

Understand the risk.

Analyze and evaluate what could happen to your medical device. The concept of preparing for the worst is not fun to consider, but it's imperative for longstanding success. R&Q has seasoned experts in all aspects of post-market surveillance and can help you put a plan in place: carefully, yet quickly and efficiently.

Keep the momentum.

CAPA, complaint, and safety risk monitoring are three critical components that ultimately allow your medical device company to succeed. And if you face an unfortunate recall, R&Q has successfully handled many of them and can help you. We will diligently work with your team to ensure all details of the recall are squared away.

FEATURED CONTENT: Read our CAPA Remediation and Supplier Quality Remediation case studies.

 


Remediation

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Unlike competitors, R&Q provides best practice strategic and tactical solutions to address 483 findings, warning letters, and consent decrees.

We also help medical device companies proactively improve their systems before anything happens.

We do:

  • Strategic and hands-on guidance for rapidly optimizing quality systems
  • Evaluate and prioritize quality and regulatory risks during due diligence and mitigate risks during integration
  • Experienced third-party perspective to access gaps and methodically improve processes
  • Partnering with third-party legal firms to ensure legality of 483 and warning letter responses, avoiding legal pitfalls
  • Efficient project team assembly, tailored for the remediation process
  • Conducting effective root cause analysis and deployment of optimized corrective action
  • Augmenting of staff to address remediation efforts while simultaneously running the business
  • NET Promoter Score 9.3 out of 10 proves customer loyalty and success
  • Design History File (READ our DHF Remediation case study)

A sampling of our testimonials:

"We have many firms working on this remediation and R&Q is by far the best we have used to date. From their program management to their technical skill they far outpace the others." - VP of Regulatory and Quality, Remediation Support, Large Medical Device Company
"The R&Q team members are knowledgeable and take the time to tailor their services to 'fit your real needs.' If you are in need of regulatory and quality support in the med-tech industry I recommend reaching out to R&Q." - VP of Quality and Regulatory Affairs, Remediation Support, Large Multinational Medical Device Company

 

View and print our remediation flier

 

Contact us today by completing the form below.