Medical Devices & IVD Services (MDR/IVDR)

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Medical Devices & IVD Services (MDR/IVDR)

At GLORAMP, we help medical device and IVD manufacturers navigate the complex landscape of EU MDR, IVDR, UKCA, and FDA regulations — from strategy to certification. 

Regulatory Strategy & Technical Documentation

Our capabilities include:

  • Device and IVD classification and regulatory pathway definition
  • GSPR mapping and compliance gap assessment
  • CER/PER authoring and evidence appraisal
  • SSCP/SSP documentation and validation
  • PMS, PMCF, and PMPF plan development and implementation
  • Coordination with Notified Bodies (NB) and competent authorities
Global Market Access

We support seamless registration and compliance across EU MDR/IVDR, UKCA, and FDA pathways.

  • Regulatory submission planning and dossier preparation

  • Authorized Representative (EC REP) and UK Responsible Person (UKRP) coordination

  • Labeling, UDI, and vigilance management

Device Quality Management Systems (QMS – ISO 13485)

Our experts design and implement robust ISO 13485-compliant QMS frameworks, ensuring operational excellence and inspection readiness.

  • QMS establishment and documentation

  • Internal audits and gap assessments

  • Staff training and competency development

  • Continuous improvement and CAPA programs

Book a free call

Let’s talk! Book a free 30-minute call with a senior team member to explore how we can support your goals.

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