Medical Electronics Symposium Conference Proceedings


MEDICAL DEVICE REGULATORY COMPLIANCE - OVERCOMING PHYSICAL AND PSYCHOLOGICAL BARRIERS

Authors: Robert Koung, David Lindley, and Warwick Magee
Company: Crystalaid Group of Companies
Date Published: 5/19/2004   Conference: Medical Electronics Symposium


Abstract: The development and assembly of medical devices is one of the fastest growing manufacturing sectors in the world at present. Devices are becoming evermore complex, with functional abilities constantly pushing the boundaries as fast as the required technology can be developed.

The design, development and manufacture of these devices, by necessity, has to be regulated very stringently to ensure the products that reach the market are fit for purpose and are completely reliable in the hands of the end user.

This paper addresses obstacles, both physical and psychological, that companies may have to overcome in order to demonstrate that their products comply with such stringent requirements. Topics covered in the paper will address such areas as the possibility of problems where companies may have to demand a higher level of work practice discipline from employees, the often-voiced perception that compliance can only be achieved via significant financial outlay, and attempts to allay the concerns that stringent requirements for traceability of records result in resource-draining overheads.

This paper describes the vitally important aspect of successfully achieving staff awareness and understanding as to what level of compliance has to be achieved, and reaffirms the doctrine that any Quality Management System modifications must also result in positive efficiency gains for the company.

Companies aiming to achieve regulatory compliance in support of medical device manufacturing have to make a choice of philosophy and mindset at the outset. This paper discusses the typical concerns felt by most companies. It then proceeds to demonstrate how the Crystalaid Group of Companies took such anxieties and turned the situation around, actively informing customers and competitors alike of our passionate objective to achieve full compliance and improved business efficiency.

Key words: regulatory compliance, awareness, psychological.



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