Medical Devices Regulatory Compliance

Medical Device organisations are mandated to comply with the requirements of an ever increasing number of national and international standards which allows them to demonstrate high levels of safety and quality.  Organisations such as Interacoustics, Quest Medical and Orthoplastics rely on Q-Pulse to help them reduce the time, effort and cost spent managing their compliance activities.

Achieving and maintaining compliance with standards such as the FDA’s 21 CFR 820 or EU GMP from the EMEA, is of vital importance to organisations within the Medical Device industry for the design, development and manufacturing of products. There is also a requirement for Medical Device manufacturing organisations to manage quality and risk by adopting commercial compliance standards such as ISO 13485 and ISO 14971.

Medical Device organisations turn to Q-Pulse, developed by Gael Ltd, for their compliance management needs, implementing the solution as a central, electronic management system to streamline their compliance, safety and quality processes.

Q-Pulse is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management, in compliance environments including ISO 9001, GxP and ISO 13485.

Together with Q-Pulse's technical controls, our range of professional services, including supporting documentation and training, provide procedural controls that can help you put the administrative controls in place for a complete 21 CFR Part 11 solution.

To find out how Q-Pulse can help your organisation cost effectively achieve compliance to the latest regulatory standards contact us now.