Health technology: medical devices

Are you puzzled by the new MD and IVD regulations on medical devices? Are you lost in the jungle of different authorities and health technology-related requirements? We know what needs to be done and when to place your products on the market.

Our team will find fast and the most suitable routes for your company in different phases of the life cycle of your medical devices (MD or IVD devices). We can give comprehensive guidance to lead you through the regulatory jungle concerning classification, identification of requirements, documentation, quality-related issues and regulatory affairs.

Our services for medical device and IVD medical device companies:

Regulatory services:

  • Registrations, EUDAMED
  • Notified body engagement
  • Competent Authority communications
  • Borderline classifications

Market access

  • Price and reimbursement strategies 
  • Price and reimbursement applications 
  • Comparator and market evaluations 
  • Health technology assessments (HTA) 
  • Budget Impact models (BIM) 
  • Cost effectiveness analysis in Finnish setting based on global models 
  • Treatment pathway evaluations 

Quality management

  • ISO 13485, GMP, GDP
  • Establishment of QMS
  • Audits

Technical documentation

  • Verification and validation reports
  • Clinical evaluation
  • Biological safety evaluation (ISO 10993)
  • Risk management (ISO 14971)
  • IVD performance evaluation
  • Literature searches
  • Data analysis

Post Market Surveillance

  • PMS-plans
  • Post market surveillance reports
  • PSUR
  • PMS data collection and data analysis

Labelling, IFUs and marketing material

  • Traceability, UDI
  • Medical translations
  • Promotional material review

Personnel leasing

  • Person Responsible for Regulatory Compliance MDR/IVDR Article 15
  • Quality manager

Trainings

  • Basics of MDR for manufacturer
  • Basics of IVDR for manufacturer
  • Basic of quality management systems for medical devices
  • Biological safety evaluation
  • Clinical evaluation

 

Correct classification spares you many problems

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