MDSAP is a regulatory audit program that was jointly developed by 5 regulatory bodies. It allows a medical device manufacturer to have a single quality management system audit to satisfy the requirements of all participating regulatory authorities.
The 5 participating regulatory authorities (Ras):
|Theurapeutic Goods Administration (TGA)
|Agencia Nacional de Vigiancia Sanitaria (ANVISA)|
|Theurapeutic Goods Administration (TGA)|
|Food and drug Administration (FDA)|
|JPAL (Japanese Pharmaceutical Affairs Law)|
In today’s hi-tech world, medical devices manufacturers are facing challenges to come out a safe product and beneficial devices to the world. DQS provides conformance assessments in accordance with the regulatory requirements in respective country.
Manufacturers demonstrate to DQS their compliance to relevant management system as well as respective regulatory requirements during DQS conformance assessment. Furthermore, manufacturers also need to understand the requirements of devices in situation where the standard or guideline for the respective devices is ruled.
Our services are designed to align with the steps of management system. Individual clients need to understand what is best practice, how to achieve it and ensure that it remains an ongoing habit.
We offer demanding quality management certification, reviews and product certifications for medical device manufacturers around the world. We aim to be the preferred certification partner and please contact DQS for your medical device assessment solutions.