Quality management system Preparation and Training
- ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes.
- EN ISO 14971:2009 Medical devices. Application of risk management to medical devices.
- EN ISO 10993-1:2009 Biological evaluation of medical devices. Evaluation and testing.
- EN 980:2008 Symbols for use in the labeling of medical devices.
- EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance
- IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
- OHSAS 18001:2007 International Occupational Health and Safety Management Standard.
- ISO 14001:2004 Environmental Management Systems
- ISO 27001:2005 Information Security Management Systems (ISMS).
- BS 25999-2 2007 Business Continuity Management (BCM)
- ISO 50001:2011 Energy Management
International regulations Preparation and training
- Preparation of technical file
- MDD medical device directive 93/42/EEC as amended 2007/47/EC
- integration with other directives including In-vitro diagnostic device, active implantable device, personal protective equipment.
- GHTF requirements
- Canadian medical device Regulation
- TGA Australian Requirements
- 21CFR820 USA Medical device requirements
- registration of products worldwide
- 510k and PMA for FDA
validation and testing
- Microbiology testing
- ETO validation
- Clean room validation
- packaging validation
- ETO residue
- aging study
- biocompatibility study as we are representing international labs
- device bench marking
- environmental monitoring testing
- thermal mapping
- testing for law 4, ISO 14001, law 12 OHSAS 18001 (Environmental measurements)
Good Practices Preparation and training
- GMP Good Manufacturing practice
- GLP Good Laboratory Practice
- GHP Good Hygiene Practice
- GDP Good Distribution Practice
- onsite training
- on line training
- Quality Preparation
- Technical Service
- Validation & Testing