Regulatory & Consulting

Consulting: the cornerstone of your device development

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Comprehensive regulatory compliance checks

Integrated approach to commercialization

Expert trial design

Innovative technology for a medical device is only the beginning. You also need a solid development plan that can be adapted along the way. Compelling evidence and a convincing value proposition matter. Competing priorities and differing stakeholder definitions of value require creative, connected strategies that maximize each stage of development. And – as evidence is gathered – it informs and iterates regulatory, reimbursement, clinical and post-market strategies.

As advisors specialized in medical device and diagnostic development, we can help you design and execute integrated strategies for robust evidence generation and successful commercialization. 

  • Regulatory Affairs

    Begin with the end in mind

    You need to think ahead and ask the right questions to uncover potential regulatory risks that could set you back. 

    Are my preclinical studies addressing biocompatibility endpoints?  

    Do my predicates align with reimbursement and regulatory goals?

    What are the regulatory compliance requirements of my targeted global marketplace?

    Efficiently integrating your market approach from conception to completion ultimately saves you time, money and effort. By looking at product classification, required quality standards and required testing upfront, you can avoid unnecessary testing and facilitate discussions with regulators and notified bodies to prepare for regulatory submissions. 

    Our regulatory specialists start early, examining every aspect of regulatory compliance to identify potential issues that could impact your design, materials, manufacturing methods or financial plans. Leveraging worldwide experience with regulatory agencies, we cultivate novel, targeted strategies to help you achieve regulatory approval in your target markets.

    Comprehensive regulatory consulting capabilities:

    • Regulatory Strategy
    • Project Management
    • Device Claims Development
    • Design Control Support
    • Risk Management Support
    • Biological Safety Evaluation
    • Labeling
    • Regulatory Submissions
    • Regulatory Compliance Consulting
    • Audit Preparation & Support
    • Regulatory Interface Support
    • Registration & Licensing Support
    • Clinical Evaluation Reports (CERs)
    • Post-Market Clinical Follow-up Plan Support

    Changes to EU Clinical Trial Regulation No.536/2014

  • Quality Systems

    Need comprehensive Quality Systems support for FDA quality system regulation (QSR) and ISO 13485 compliance? No matter your size, we can scale the quality system to your goals, products and culture: 

    • Integrate regulatory and quality strategies using risk-based approaches. 
    • Design and implement quality systems.
    • Maintain innovative quality strategies that address device nuances and grow with your device during the product life cycle.
    • Research regulatory body “hot buttons” for proactive risk-mitigation strategies to avoid regulatory sanctions.

    Quality Systems. Quality Support.

    • Quality Systems Strategy
    • Quality Compliance Support
    • SOP Drafting & Review 
    • Document Control System Implementation
    • Remediation Programs
    • Quality System Audits
    • Risk Management Support
  • Health Economics and Reimbursement

    It is critical to fully understand the current health economic and reimbursement landscape. Regulatory clearance only gives medical device companies the opportunity to market a device – it does not ensure payment.

    An integrated approach supports the entire commercialization journey from early concept through post-market launch. Improve your chances of market acceptance for a faster return on investment, with guidance from our reimbursement specialists.

    Tools to help you achieve reimbursement:

    • Reimbursement Landscape Assessments
    • Strategic Planning for Reimbursement
    • Evidence Development Planning
    • Input to Clinical Study Design and Endpoints
    • Payer Initiatives
    • Health Economics Strategy
    • Health Economic Assessments
    • Health Economics Tool Development
    • Payer Insights and Payer Mix Analysis
    • Pricing Strategies
  • Clinical Sciences

    Thoughtful trial design and execution achieves the most efficient acquisition of sound scientific evidence on your device. Every trial has unique characteristics. Optimizing the appropriate study design to get the evidence you need, saves you both time and money during the operational phase of your project. 

    Trusted, proven and respected

    Our advisors’ deep experience in both pre-market and post-market studies can quickly pinpoint areas for improvement or efficiency, identify unusual findings in the data and work with you to anticipate and overcome challenges. All while obtaining the necessary evidence at the right time in your product life cycle.

    • Clinical Strategy
    • Clinical Study Design
    • Clinical Study Operations
    • Site Management
    • Site Monitoring Services
    • Database Development & Management
    • Data Management 
    • Biostatistics Consulting
    • Medical Writing
    • Data Monitoring Committee (DMC)/Data Safety Monitoring Board (DSMB) Management
    • Clinical Events Committee (CEC) Management
    • Clinical Compliance/Auditing
    • Inspection Preparedness 
    • Training, Sponsor and Site
    • Clinical Evaluation Reports (CERs)
  • Device Consulting

    Sometimes the key to success is found in altering the business approach, not the product. That’s where our Device Consulting solutions come in. Our savvy medical device strategy advisors know the ins and outs of the new value-driven health economy and how to navigate through today’s marketplace landscape – and landmines. We can examine every detail of your development process to uncover opportunities, reduce cost and improve timelines.

    • Evidence Development Plans
    • Medical Device Strategy
    • Risk Assessment & Management
    • Acquisition Due Diligence
    • Integration Planning & Management 
    • Merger & Acquisition Support

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