Qosina Regulatory Services

    Regulatory support, every step of the way.

    From QMS gaps and submission questions to changing requirements and regulatory follow-up, Qosina helps medical device teams understand what comes next, get the right documents in order and move forward with less stress.

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    A sample experience people remember

    What We Support

    Services built around regulatory pressure points

    Quality & Regulatory Compliance

    • QMS audits and gap analyses
    • Audit preparation and mock audits
    • FDA 483s, Warning Letters and remediation
    • EU MDR, FDA, ISO 13485 and MDSAP support
    • Field actions, recalls and adverse event reporting
    • Registration, listing and marketing requirements

    Regulatory Strategy & Submissions

    • Pre-Subs, 510(k)s and PMA support
    • CE-marking under EU MDD and EU MDR
    • Design dossiers, technical files and medical device files
    • Health Canada, TGA and global authorizations
    • Clinical Evaluation Reports
    • Labeling and marketing material review

    Expert Consulting & Support

    • Product development and project support
    • Supplier management and auditing
    • UDI implementation and listing
    • eQMS selection and rollout consultation
    • Manufacturing qualification, verification and validation
    • ISO 14971 risk management support
    Match Me With the Right Service

    Regulatory is heavy. You do not have to carry it alone.

    Get help sorting through the requirements, documents and next steps that are slowing you down.

    Talk to Our Regulatory Team

    Common Pressure Points

    When the details start slowing you down

    These are the moments when regulatory support can help teams sort through what matters, what is missing and what comes next.

    “We do not know what comes next.”

    Clarify submission, QMS, market-specific or follow-up requirements.

    “The FDA came back with questions.”

    Understand what is being asked, what may be needed and how to respond.

    “Our documents are not where they need to be.”

    Identify missing pieces, close gaps and organize the work before it becomes a bigger issue.

    “Regulations keep changing.”

    Navigate requirements across markets without chasing every update alone.

    “This is taking over the project.”

    Reduce the pressure so your team can stay focused on the product and business.

    “We need support, not intimidation.”

    Get practical help without the big-firm overwhelm.

    A sample experience people remember

    Regulatory Insights

    Regulatory News and Insights

    Announcements, guidance and practical frameworks from Qosina's regulatory team.

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