Services

Comprehensive MDR & IVDR consulting services for medical device manufacturers. Expert guidance on technical documentation, clinical evaluation, and regulatory c...
Our Services

Your Trusted Partner in Medical Device Regulatory Compliance

01 - 05

Assessment & Gap Analysis

02 - 05

Strategy Development

03 - 05

Implementation Support

04 - 05

Submission & Certification

05 - 05

Ongoing Compliance

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Our Services

MDR
(Medical Device Regulation) Consulting

Expert MDR consulting for medical device manufacturers. Technical documentation, clinical evaluation & regulatory strategy.

  • Technical documentation preparation (Annex II & III)
  • MDR gap analysis and transition planning
  • Clinical evaluation report (CER) support
  • Notified Body submission coordination
  • Post-market surveillance strategy
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IVDR
(In Vitro Diagnostic Regulation) Consulting

Comprehensive IVDR consulting for IVD manufacturers. Classification, performance evaluation & technical documentation.

  • IVDR classification determination
  • Performance evaluation planning (PEP)
  • Technical documentation preparation
  • IVD registration support
  • Ongoing compliance assistance
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ISO 13485:2016 Consulting

ISO 13485 quality management system consulting. QMS implementation, documentation & certification support.

  • QMS implementation and gap analysis
  • Documentation development (SOPs, forms)
  • ISO 13485 internal audit
  • Supplier qualification and auditing
  • Pre-certification readiness
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ISO 14971 Risk Management Consulting

ISO 14971 risk management consulting. Benefit-risk analysis, FMEA & risk file development.

  • Risk management file development
  • Benefit-risk analysis and documentation
  • FMEA (Failure Mode and Effects Analysis)
  • Risk control measures implementation
  • Ongoing risk file maintenance
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Biocompatibility Documentation Consultancy

Biocompatibility testing and documentation per ISO 10993. Test planning, chemical characterization & support.

  • ISO 10993-1 test plan development
  • Chemical characterization studies
  • Biocompatibility test coordination
  • Test report review and validation
  • Biological safety file preparation
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Post Market Surveillance (PMS) Consulting

MDR-compliant PMS system setup. PMS plan development, PSUR preparation & trend analysis.

  • PMS plan development and implementation
  • Periodic Safety Update Report (PSUR)
  • Trend analysis and vigilance reporting
  • Complaint handling system setup
  • EUDAMED PMS data management
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Post Market Clinical Follow up (PMCF) Documentation Consulting

PMCF plan and report development for MDR compliance. Real-world evidence & clinical data collection.

  • PMCF plan development
  • PMCF report preparation
  • Real-world evidence collection
  • Literature surveillance and analysis
  • Continuous clinical evaluation updates
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Registration Strategy Consulting

Strategic regulatory consulting for global market access. EU, FDA, UKCA & international registrations.

  • Regulatory strategy development
  • Multi-country registration planning
  • EUDAMED registration support
  • FDA listing and registration guidance
  • UKCA marking and country-specific submissions
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Proven Regulatory
Success

35+

Clients

125+

Projects Completed

2200+

Pages of Documentation

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Call us today at +382 68 682 766

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