New Product Development

IVD, Combination, and Medical Device Development Consulting

Make Your Medical Device Happen With Expert Consulting, Tailored Strategies, and Smooth Regulatory Pathways

IVD, Combination, and Medical Device Development Consulting

RQM+ is your single stop for IVD, combination product, and medical device development consulting services. Our regulatory, quality, clinical, and reimbursement consulting help transform your innovative ideas into market-ready products. With decades of experience, we understand the ins and outs of new product development. We guide you through the process so you can take your device from initial concept to global market release. 

It doesn’t matter whether you’re a small company designing a cutting-edge diagnostic or a large company developing a new auto-injector. We’re here to make MedTech happen for you — faster, safer, better. 

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Comprehensive Product Compliance Support

At RQM+, we go beyond standard regulatory frameworks to ensure your product is compliant across all critical global regulations. We cover: 

  • Regulatory Essentials

    QMSR, EU MDR, IVDR, and ISO 13485

  • Artificial Intelligence Act

    Compliance for AI-driven medical technologies

  • Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)

    Ensuring product safety and environmental sustainability

  • Battery Regulation

    Supporting MedTech devices with integrated battery systems

  • Packaging and Packaging Waste Regulation (PPWR)

    Sustainable packaging compliance for global markets

Key New Product Development Benefits

When you collaborate with RQM+, you receive benefits that directly impact your product’s success and improve patient outcomes: 

  • Reduce Rework and Delays

    Many 510(k) submissions are rejected at the Refuse to Accept (RTA) stage due to avoidable errors (e.g., incomplete documentation or improper formatting). Our experts have supported hundreds of successful FDA and EU submissions. We help you get it right the first time.

  • Navigate EU MDR and IVDR

    Notified body survey found that only ~25% of notified bodies considered initial EU MDR submissions complete. This can lead to prolonged review timelines of 18 months or more. Our former regulators and notified body reviewers ensure your submission is complete, clear, and aligned with expectations.

  • Regulatory Expertise

    Our team includes former FDA reviewers, notified body leaders, and global regulatory consultants who understand the nuances of international market requirements. We help you anticipate challenges before they happen.

  • Scalable Support for Any MedTech Company

    Whether you’re a startup bringing your first device to market or a global MedTech leader expanding into new regions, we tailor our regulatory, clinical, and reimbursement strategies to your product.

Core Medical Device Development Consulting Services

We provide comprehensive services tailored to ensure your product’s success, including: 

  • FDA submissions:  
    • 510(k) Premarket Notifications 
    • De Novo Applications 
    • Premarket Approvals (PMAs) 
    • Emergency Use Authorization (EUA) 
    • Request for Designations (RFDs) 
    • Pre-Submission (Q-Sub) 
    • Investigational Device Exemptions (IDEs)  
    • Breakthrough Designation Requests 
    • Humanitarian Use Device (HUD) 
    • Safer Technologies Program (SteP)  
    • Request for Information (513(g)) 
    • Drug-Device Combination Products (IND, NDA, ANDA, BLA – Device portion only) 
  • CE marking and MDR/IVDR compliance 
  • Regulatory pathway analysis and strategic planning 
    • Worldwide regulatory strategies 
    • Submission review (U.S. or EU) 
    • Refuse to accept or hold letter support 
    • Acquisition due diligence review 
    • Biological evaluation plans/reports 
    • Change impact assessments 
    • Marketing and labeling review 
    • Registrations and listings 
  • Reimbursement strategies and approvals 
  • Development of Design History Files (DHF) and technical documentation 
  • Risk management plans and safety analyses 
  • Verification/validation (V&V) support 
  • Manufacturing and supplier quality 
  • Expertise in U.S., EU, U.K., Canadian, and APAC regulatory frameworks 
  • Integrated support for combination products and IVDs 
  • Ongoing collaboration with notified bodies in the EU and the FDA in the U.S. 
  • QMS development 
  • QMS audits 
  • Literature searches and clinical strategy 
  • Clinical investigation plans/protocols 
  • Draft study documents 
  • Clinical study approval 

History of Success

  • Supported 19 of the top 20 medical device manufacturers 
  • Over 40 years of regulatory consulting expertise 
  • Proven success navigating U.S., EU, and U.K. regulatory landscapes 
  • Recognized as leaders in design assurance and risk management

Therapeutic Area Expertise

Our expertise extends to numerous therapeutic areas, including:

  • Oncology
  • Respiratory care
  • General surgery
  • Women’s health
  • Infectious disease
  • Orthopedics and spine
  • Urology
  • Neurology
  • Wound care
  • Ophthalmology
Explore Our Expertise

Make Your MedTech Happen

Ready to bring your vision to life? Our medical device development consulting services can get you there.

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