© 2010 Pink Associates | Terms and Conditions | Site created by Platinum Arrow
- was established in September 2007 in order to address the educational needs of the
medical device design, regulatory and quality assurance professionals
- work for Notified bodies in order to assess manufacturers against the requirements
of International Medical Device regulations and standards by performing Technical
file and Quality Management system audits
- undertake research and development of unique training materials for e-learning either
through this website or can work with you onsite to help identify, develop and deliver
learning materials for your own organisation
- are not design or regulatory consultants as we concentrate specifically on formal
outcome evaluation and academic research associated to the effectiveness of the theories
and practices adopted by manufacturers to address regulatory and quality management
systems standards