Our Services

Comprehensive regulatory expertise tailored to your product portfolio. From initial strategy through certification and beyond.

EU 2017/745

MDR Compliance Services

Navigate the EU Medical Device Regulation with confidence. We provide end-to-end support for manufacturers transitioning from MDD to MDR or seeking first-time certification.

The MDR introduced significant changes to the regulatory landscape, including stricter clinical evidence requirements, enhanced post-market surveillance obligations, and new classification rules. Our team has successfully guided dozens of manufacturers through this transition.

  • Gap Analysis & Transition Planning - Assess your current documentation against MDR requirements and develop a prioritized action plan.
  • GSPR Mapping - Systematic mapping of General Safety and Performance Requirements with clear traceability to your technical documentation.
  • Technical Documentation Development - Complete technical file creation or remediation following MDCG guidance documents.
  • Clinical Evaluation Reports (CER) - MEDDEV 2.7/1 Rev 4 compliant clinical evaluations, literature reviews, and clinical development strategies.
  • Post-Market Surveillance Systems - PMS plans, PMCF protocols, periodic safety update reports (PSUR), and vigilance procedures.
  • Notified Body Liaison - Submission preparation, audit support, and response coordination for efficient certification.
EU 2017/746

IVDR Transition Services

The In Vitro Diagnostic Medical Devices Regulation represents a fundamental shift in how IVDs are classified and assessed. We help you navigate these changes efficiently.

With significant changes to the classification system and the introduction of performance evaluation requirements, many IVD manufacturers face new regulatory obligations. Our expertise ensures your transition is smooth and your products remain compliant.

  • Classification Assessment (Class A-D) - Expert determination of IVDR classification based on intended purpose and risk profile.
  • Performance Evaluation Reports (PER) - Comprehensive performance evaluation including analytical, clinical, and scientific validity evidence.
  • Scientific Validity Documentation - Establishing the association between analytes and clinical conditions with robust scientific evidence.
  • Post-Market Performance Follow-up (PMPF) - Design and implementation of PMPF plans to demonstrate ongoing performance.
  • EU Reference Laboratory Coordination - Support for products requiring batch verification or type examination.
MDR Article 117

Combination Products

Drug-device combination products require specialized expertise at the intersection of pharmaceutical and medical device regulations. We bridge this gap.

Article 117 of the MDR establishes specific requirements for devices used in combination with medicinal products. Whether your product is integral, co-packaged, or referenced, we provide clear regulatory pathway guidance.

  • Regulatory Pathway Assessment - Determine whether Article 117 applies and identify the appropriate conformity assessment route.
  • Integral vs. Co-packaged vs. Referenced - Classification guidance for different combination product configurations.
  • EMA/Notified Body Coordination - Facilitate communication between regulatory bodies for efficient assessment.
  • Drug-Device Interface Documentation - Technical documentation addressing the unique aspects of combination products.
  • Pre-filled Syringes & Injection Devices - Specialized expertise in common combination product formats.
  • Quality System Alignment - Harmonizing ISO 13485 and pharmaceutical GMP requirements.

Let's Discuss Your Regulatory Needs

Every product has unique requirements. Contact us for a tailored approach to your compliance challenges.

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