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Sunday, February 18, 2018
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Medical Devices

Quality management system Preparation and Training

  1. ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes.
  2. EN ISO 14971:2009 Medical devices. Application of risk management to medical devices.
  3. EN ISO 10993-1:2009 Biological evaluation of medical devices. Evaluation and testing.
  4. EN 980:2008 Symbols for use in the labeling of medical devices.
  5. EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance
  6. IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
  7. OHSAS 18001:2007 International Occupational Health and Safety Management Standard.
  8. ISO 14001:2004  Environmental Management Systems
  9. ISO 27001:2005 Information Security Management Systems (ISMS).
  10. BS 25999-2 2007 Business Continuity Management (BCM)
  11. ISO 50001:2011 Energy Management

International regulations Preparation and training

  1. Preparation of technical file
  2. MDD medical device directive 93/42/EEC as amended 2007/47/EC
  3. integration with other directives including In-vitro diagnostic device, active implantable device, personal protective equipment.
  4. GHTF requirements
  5. Canadian medical device Regulation
  6. TGA Australian Requirements
  7. 21CFR820 USA Medical device requirements
  8. registration of products worldwide
  9. 510k and PMA for FDA

validation and testing 

  1. Microbiology testing
  2. ETO validation
  3. Clean room validation
  4. packaging validation
  5. ETO residue
  6. aging study
  7. biocompatibility study as we are representing international labs
  8. device bench marking
  9. environmental monitoring testing
  10. thermal mapping
  11. testing for law 4, ISO 14001, law 12 OHSAS 18001 (Environmental measurements)

Good Practices Preparation and training

  1. GMP Good Manufacturing practice
  2. GLP Good Laboratory Practice
  3. GHP Good Hygiene Practice
  4. GDP Good Distribution Practice

Supporting Training

  1. onsite training
  2. on line training

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