Interacoustics implement Q-Pulse for fast and reliable quality system
Part of The William Demant Group, Danish medical device manufacturer, Interacoustics, designs and manufactures equipment across the whole audiological spectrum. Their products range from small portable devices to full clinical instruments, and can be found all over the world wherever hearing health care is practiced.
To comply with strict industry standards and regulations, including ISO 13485, the FDA’s 21 CFR 820, the European Medical Device Directives, and Canadian Medical Device Regulations (CMDR), Interacoustics required a single system to manage their regulatory compliance activities - document control, auditing, assets, and corrective and preventive actions (CA/PA’s).
Q-Pulse, the quality management solution (QMS) developed by Ideagen, was implemented to help them achieve and maintain regulatory compliance through improving the management of their compliance activities.
Benefits
- Compliance achieved with FDA 21 CFR Part 820, ISO 13485 and European Medical Device Directives
- Q-Pulse was scaled to meet the needs of all three offices in Denmark, Germany and the U.S
- Q-Pulse extends beyond the quality department and is used by production, design, marketing, product and management
- Allowed organisation to identify opportunities for continual improvement, from tracking corrective and preventive actions, to measuring the effectiveness of the QMS
We see Ideagen as a company with a very high focus on the needs of the customer. Q-Pulse has become a fast and reliable system for handling a great deal of our quality issues.
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