• Intercompany Training NP EN ISO 13485:201
  
• 16 hours (2 days)
  
• Online

• Quality Directors or Managers
• Management Representatives
• Process Managers within the scope of Medical Devices
• Auditors and Consultants

General objectives
Provide participants with skills that allow them to actively participate in the maintenance and continuous improvement of the medical device quality management system – requirements for regulatory purposes.

Specific objectives

At the end of the training, trainees will be able to:

• Understand the context of the reference standard;
• Know its connection to the regulatory requirements applicable to the area of Medical Devices;
• Identify relevant aspects for the maintenance and continuous improvement of the quality management system;
• Understand and identify connections with other normative references for support and guidance.

Knowledge of the Legal Diplomas applicable to economic operators operating in the field of medical devices, both European and national legislation, namely Regulation (EU)2017/745 and Regulation (EU)2017/746 (current versions), DL 145/2009 and Port 256/2016.
During the action, trainees must be in possession of the ISO 13485 Standard (either in Portuguese or in English).

• Origin of the standard;
• Application of the standard;
• Regulatory requirements;
• Analysis of regulatory requirements: General and documentation requirements, Management responsibility, Resource management;
• Product realization, Measurement, Analysis and Improvement;
• Connection with other support references;
• Harmonized standards;
• CE marking;
• Various exercises throughout the action;
• Clarification of doubts;
• Final assessment with 10 multiple choice questions.

Strongstep Trainer

• General Director at FLUXINTELIGENTE – Auditing and Consulting for Quality
  
• MBA, Universidad Camilo José Cela, Madrid
  
• Pharmacy Degree, Faculty of Pharmacy, University of Lisbon
  
• Pharmacy Interchange Programme, Missouri Pharmacy Association, MO, USA
  
• Data Protection Officer (personal data protection and information security)
  
• Lead Auditor and Trainer (ISO 9001; ISO 45001; ISO14001; ISO 13485; ISO 14971; ISO 21001, GMP, GDP, Good Laboratory Practices, Good Pharmacy Practices, ISO22001; ISO 29993, IFS; among others 
  
• Member of the Association of Auditors of the Order of Pharmacists with active professional card
  
• External Lead Auditor (certifying companies eiC, TÜV Rheinland and APCER)
  
• Health assessment expert
  
• Member of CT187 at the Portuguese Quality Institute (IPQ)
  
• Trainer with CCP