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MDSS
serves clients' specific needs with changes
of products and regulations.  Each client is unique and MDSS customizes the solution for each client individually.

 
Technical Documentation
consulting and Support:

• Preparation and Evaluation for submission to European Notified Bodies
  and non-European health authorities according to the appropriate guidelines

Risk Management
Consulting and Support:

• According to EN ISO14971
• Preparation of risk management file
  • Risk management plan
  • Risk analysis (FMEA)
  • Risk management report (summarizing)
    
• In House training before implementation
• Manage: identification, evaluation and documentation of risks in risk Management table
  

Quality Management
Consulting and Support:

• According to EN ISO 9000 et sqq. and EN ISO 13485

• Developing, establishing and maintaining
  • Handbook
  • Applicable Standard Operating procedures (SOP)
    
• In House training and periodic internal audits

Classification
Consulting and Support:

• Medical Devices and borderline products
• Demarcation according to the relevant standards and guidelines between Medical products
  • Medicinal products
  • Cosmetics
  • Medical Devices
    
• Expert Reports
• Justification towards the Notified Body and Competent Authority

Clinical Evaluation
Consulting and Support:

• Project Management
• Preparation according to guideline MEDDEV 2.7.1
  • Clinical Evaluation Plan
  • Execute the scientific literature
  • Obtain medical expertise's
  • Clinical evaluation report

Training / Assistance

• In House Training
• Complimentary with the clients’ needs
  • General overview EEA's and US approval procedures
  • All related Questions
  • Normal requirements
    
• Market Authorisation for the devices
  • EEA and Switzerland
  • USA