Non-Conformance Software – Medical Devices
As a manufacturer in the Medical Device market, you are mandated to comply with the requirements of an increasing number of national and international laws and regulations; whether the FDA's 21 CFR 820 or EU GMP from the EMEA, the design, development and manufacturing of products in a risk-based, quality-assured environment is an absolute prerequisite to operate in this market.
Additionally, the medical device manufacturing sector further strengthens its commitment to managing quality and risk by adopting commercial compliance standards such as ISO 13485 and ISO 14971.
With the penalties for failing to comply with laws and regulations also increasing, managing compliance with legal and regulatory requirements is increasingly important in reducing time and effort, reducing the duplication of effort and reducing resource expenditure.
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 to put the administrative controls in place for a complete 21 CFR Part 11 solution.
Contact us now at medicaldevice@gaelquality.com to discover how Q-Pulse can enable you to improve efficiency, accelerate time to delivery and ensure regulatory compliance.
