Regulatory
Whether you’re just beginning to develop a new product or already have one on the market, the importance of a strong regulatory team is crucial.
Strategic Regulatory Affairs and Market Access
In today’s dynamic regulatory landscape, having a robust regulatory team isn’t just beneficial—it’s essential to the success of both new and established products. Whether you’re at the early stages of development or managing an in-market device, a strategic regulatory approach is the foundation for navigating complex requirements, accelerating market access, and sustaining compliance in a rapidly evolving industry.
Trinzo’s Regulatory Affairs and Market Access services empower medical device, IVD, and combination product companies to navigate complex global regulatory landscapes and achieve efficient market access.
For decision-makers looking to streamline regulatory pathways and optimise compliance, our client-centric approach combines strategic insight with execution excellence, ensuring readiness for every regulatory milestone.
Regulatory Strategy
A well-defined regulatory strategy is essential for navigating complex compliance landscapes. Trinzo’s strategy experts work with you to chart a path that includes FDA submission types—such as 510(k), PMA, and de novo applications—and CE mark certification requirements.
We assess your product’s regulatory needs, potential market barriers, and plan an efficient route to regulatory service success.
- Regulatory Intelligence
- Regulatory Strategy
- Pre-market Global Registration Support
- FDA Q-submission
- Agency Meeting Prep and Representation
- FDA Submission – PMN 510(k), PMA, DeNovo, IDE
- CE Mark Certification – EU MDR and EU IVDR
- Facility Registration
- Post Market Sustaining Product Lifecycle
- Change Management Strategy and Submission
Device Design and Development
We offer specialised guidance throughout the design and development stages, embedding compliance into your product’s core. Our team collaborates with your designers and engineers, ensuring that regulatory standards are met early and consistently, making it easier to achieve FDA and EU approvals and reducing the risk of costly redesigns.
Design Verification & Design Validation
Our Design Verification & Validation service provides support and guidance in the preparation of plans and protocols to confirm your device meets all regulatory specifications. We design verification and validation testing protocols that satisfy both clinical and regulatory requirements, preparing your product for essential FDA and EU evaluations—crucial steps in gaining approvals like 510(k) clearance or CE mark certification and instilling confidence in product safety and performance.
Classification and route to conformity
With a deep understanding of regulatory classifications, we determine the correct classification for your device and identify the optimal route to conformity. Trinzo’s experts evaluate your device, determine the correct FDA classification, and align with applicable EU medical device classifications. Our team identifies the optimal regulatory pathway, providing a clear route to market based on product type and intended use.
Technical File Preparation
Comprehensive technical documentation is key for FDA and EU submissions. Trinzo’s technical file preparation service provides fully compliant documentation that includes essential reports like Safety and Performance Summaries, Clinical Evaluation Reports (CER), and Risk Management Files. This complete and structured documentation is designed to meet all regulatory expectations for product safety, performance, and clinical evidence.
Clinical Regulatory Services
Clinical validation is a critical part of regulatory compliance. Our Clinical Regulatory Services include Clinical Evaluation Reports, Safety Performance Summaries, and support for clinical and performance investigations. Whether preparing for an FDA pre-market submission or compiling evidence for CE marking, Trinzo’s team manages all clinical documentation to demonstrate robust clinical evidence and ensure regulatory acceptance.
- Clinical Evaluation Plan and Report (CEP and CER)
- Clinical Investigation Plan and Report (CIP and CIR)
- Performance Evaluation Plan and Report (PEP and PER)
- Summary of Safety and Clinical Performance (SSCP/SSP)
Risk Management
Effective risk management is integral to regulatory compliance. Our team helps establish a risk management framework aligned with ISO 14971, performing risk assessments, mitigation planning, and ongoing risk evaluation.
From design through post-market, our risk management solutions safeguard patient safety and ensure compliance across global markets.
Application submission and approval
With our Regulatory Submission Management service, we support you throughout the entire submission process with precision. Our team can prepare regulatory requirements, addressing inquiries and guiding you through each step to accelerate approval and keep your project on track.
Post-market surveillance
Once your device reaches the market, our commitment continues. Through post-market surveillance, we support you in monitoring performance, gathering real-world data, and ensuring ongoing compliance. This proactive approach not only safeguards patient safety but also supports continuous improvement and adaptation to regulatory updates.
Global registration lifecycle support
Our Global Market Registration Support provides the expertise needed to manage registrations across multiple regions. From initial submission to long-term regulatory upkeep, we help you to streamline your product’s entry and maintenance in global markets, ensuring compliance and supporting product growth worldwide.
Trinzo’s regulatory services add value at every stage of the regulatory process, combining proactive strategy with targeted execution to reduce time-to-market and enhance compliance.
As a trusted partner, we empower clients to achieve regulatory success, drive sustainable growth, and confidently enter new markets with the assurance of ongoing regulatory alignment.
Contact our team of experts today for a clear and simple path to regulatory compliance—allowing you to focus on what matters most—transforming patient care.