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Deep expertise across 20+ different regulatory disciplines
Device Classification, Technical Documentation, Clinical Evaluation, Risk Management, Standards Compliance, Post-Market Surveillance, etc.
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Extensive direct work with leading Notified Bodies
TÜV SÜD, TÜV Rheinland, DEKRA, BSI, etc.
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Broad device type expertise
Software (SaMD), Active Implantable (AIMD), In Vitro Diagnostics (IVDs), Combination Products, Drug-delivery, Surgical Instruments, Durable Medical Equipment (DME), Radiological Devices, etc.
Natural Cycles
Situation
As the first of its kind, Natural Cycles faced strict regulatory requirements for EU and US authorization of their software as non-hormonal contraception. The company requested early CE marking support under MDD, beginning a multi-year collaboration with Veranex.
Successes
We concluded the copiloting process with a complete document review by our clinical evaluation team. We submitted a finalized clinical evaluation to the Notified Body, which was approved in March 2022, helping Natural Cycles successfully close a clinical documentation review.
Services by Veranex
- Phase 1: QMS creation and implementation, revision of Standard Operating Procedures, organized company training on relevant standards (e.g., IEC 62304), regular QMS audits per ISO13485/MDR/QSR, and revised Technical Documentation including risk analysis
- Phase 2: Organized two-day clinical evaluation training to support MDR-compliant clinical evaluation file creation
- Phase 3: Defined strategic and methodological aspects of clinical evaluation plan and report, including MEDDEV 2.7/1 rev 4 compliant literature search strategy, state-of-the-art description and publication appraisal, safety/performance parameter definition for comparison, appropriate clinical evaluation strategy per MDR Article 61, and analysis of all preclinical/clinical data.
Quality Consulting
Transform regulatory compliance from a hurdle into a competitive advantage with our quality system expertise that integrates MDR requirements into operational excellence, driving both compliance and business performance.
EU Authorized Representative
Fulfill MDR Article 11 requirements with our comprehensive EU Authorized Representative services, providing the mandatory legal presence manufacturers outside the EU need while actively managing post-market obligations.
FDA Medical Device Consulting
Accelerate your US market entry with our integrated regulatory approach that aligns FDA submission strategies with your global regulatory plan, optimizing resources while maintaining compliance across multiple jurisdictions.
IVDR Consulting
Navigate the complex IVDR landscape with the same strategic expertise that distinguishes our MDR services, ensuring your in vitro diagnostic devices maintain market access with compliant technical documentation and performance evaluation reports.
