Global Medical Device Consulting

Global Medical Device ConsultingGlobal Medical Device ConsultingGlobal Medical Device Consulting

Global Medical Device Consulting

Global Medical Device ConsultingGlobal Medical Device ConsultingGlobal Medical Device Consulting
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Some of Our Services

Quality Management Systems

Quality Management Systems

Quality Management Systems

  • Benchmarking
  • Process Development, Review and Improvement
  • Audit/Inspection Preparation including support during and post action handling 
  • ISO 13485/FDA QSR/ IMDRF MDSAP
  • Training 

Regulations

Quality Management Systems

Quality Management Systems

  • Premarket Strategy and Development
  • Corrective and Preventive Action 
  • Post Market Surveillance Support including Correction and Removals 
  • Policy Support - Interpretation 
  • International Regulations including EU, China, Japan, India and Brazil 
  • Support with Regulator interaction (e.g.; pre-market submission preparation, substantive interaction)

Standards

Quality Management Systems

Standards

  • Interpretation and Training 
  • Software, AI, Cybersecurity - Regulatory Consultation 
  • Benchmarking 
  • Conformity Assessment 

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