Medical Device Regulatory & Market Access Services

Accelerate market traction through forward-thinking consulting services

  1. Medical Device Regulatory Consulting Services

    UK & EU MDR Consulting

    Tailored support to secure UKCA or CE-marking for your medical devices.

    • Technical File Production
    • Clinical Evaluation
    • Systematic Literature Reviews
    • Risk Management
    • Clinical Strategy Development
    • PMS & PMCF
    • Quality Management Systems
    • Further MDR Services
    Learn more
  2. Clinical Evaluation Reports for UK & EU market access

    Clinical Evaluation

    CEP & CER writing services with success across 250+ submissions spanning all risk classes.

    • Validated & verified CE Process with 100% acceptance
    • CERs & CEPs for UK & EU MDR compliance
    • Complete MedDev & MDCG alignment
    • Fully qualified CER signatories
    • Unlimited post-submission support until full approval
    Learn more
  3. A laboratory

    IVDR Consulting

    Ensure your in vitro diagnostic medical devices gain first-time IVDR approval.

    • Technical File Production
    • Performance Evaluation Reports
    • Systematic Literature Reviews
    • Risk Management
    • PMS & PMPF
    • Quality Management Systems
    • Further IVDR Services
    Learn more
  4. A coder at a computer

    SaMD Accelerated Approval

    Software as a Medical Device certification where time-to-market is existential.

    • Accelerated execution plan
    • Get to market 3 times faster
    • QMS & regulatory file development
    • Supporting SaMD & AIaMD applications
    • We guarantee to hit your deadlines
    Learn more
  5. US and EU flags fly together

    US to EU Market Access

    We'll leverage your device's existing FDA 510(k) approvals to accelerate UK & European certification.

    • Start with a free strategy planning session
    • Supporting for both MDR & IVDR certification
    • Authorized Representative or PRRC service
    • Expertize from experienced professionals
    • Accelerate your EU market access
    Learn more
  6. A person in a laboratory

    QMS Jumpstart

    An all-in-one Quality Management System platform will ensure you meet ISO 13485 requirements.

    • For medical devices and IVDs
    • Comprehensive template library
    • Easy-to-follow SOPs
    • Help documents, guides and videos
    • On-hand support from our QMS experts
    Learn more

Are you looking for…

  • Expert Regulatory Consulting?
  • A quote for our services?
  • Help understanding your options?

Whatever you need, contact us today for a same-day quotation.

We respect your information — Read what this means