Simplify compliance for IVD manufacturers

Develop, certify, and maintain in vitro diagnostic devices with clear regulatory guidance, practical documentation support, and expert advice that helps your team reduce compliance stress and focus on delivering safe, reliable tests.

In vitro diagnostic laboratory with regulatory documentation and certification workflow
Satisfied IVD laboratory manager in modern lab showing reduced compliance stress and achieved regulatory confidence

Reduce compliance stress for your IVDs

  • Navigate EU IVDR and FDA IVD regulations with confidence

  • Implement risk management and technical documentation efficiently

  • Ensure your tests meet safety, performance, and quality standards

Accelerate approvals and market readiness

  • Prepare submission-ready technical documentation for CE marking or FDA review

  • Ensure audit-ready processes and records from the start

  • Streamline interactions with regulators and notified bodies

IVD compliance dashboard showing organized technical documentation with completed workflow and CE/FDA approvals

Stay on track with IVD regulations

Clear guidance for every diagnostic test

We help your team understand the regulatory requirements for all IVD types, from simple lab assays to complex diagnostics, ensuring your products meet EU IVDR and FDA standards efficiently.

Ensure safety and reliability

From non-invasive tools to implantable devices, our experts ensure your product meets safety, quality, and regulatory requirements across all intended uses.

Focused on actionable results

We provide hands-on, step-by-step regulatory guidance that your team can implement immediately, so your IVD development stays on track and audit-ready without guesswork.

“Working with Monir and Fatemeh was a pleasure. Their expertise, professionalism, and timely, organized responses ensured the success of our Technical File assessment. Monir’s MDR knowledge is exceptional, and Fatemeh’s thorough, conscientious work made the process seamless.”

Logo of Kinepict, a medical and health services company
Zoltan Dr. Balogh

VP Regulatory Affairs

Practical guidance for safe and compliant IVDs

Icons representing designing tests with confidence, simplifying approvals and documentation, keeping processes organized and auditable (QMS), and maintaining compliance after product launch

Design tests with confidence

We help your teams create reliable and accurate in vitro diagnostic tests, integrating scientific validation, performance verification, and documentation best practices so every product meets regulatory expectations from the start.

Our experts guide you through IVDR and FDA pathways, helping you prepare submission-ready technical files, CE marking dossiers, and documentation packages that satisfy regulators efficiently.

We support your QA teams in implementing IVD-specific QMS practices, ensuring your validation, testing, and record-keeping are fully compliant, traceable, and ready for audits at any time.

We help your teams track test performance, manage adverse events, and perform ongoing post-market surveillance, so your IVDs remain safe, reliable, and aligned with evolving regulations.

Identify the right Notified Body for your device and manage the full application process. Include dossier submission and meeting coordination. Support a smooth and successful certification.

Support the full Performance Evaluation of your IVD device, including the Performance Evaluation Plan (PEP), Performance Evaluation Report (PER), and Post-Market Performance Follow-up (PMPF). Ensure scientific validity, analytical performance, and clinical performance are clearly demonstrated and compliant with IVDR requirements. Strengthen your submission with solid and defensible evidence.

Manage EUDAMED registration start to finish, including actor registration (SRN) and device submissions. Ensure accurate, compliant data while reducing administrative workload.

Simplify IVD compliance and launch faster