Medical Device Companies compliance to ISO 13485:2016, MDSAP, CE etc....Call us today
Savvy business leaders know how to employ outside expertise to their company advantage. Quality Workforce is a full service, hands-on quality consulting firm specializing in the establishment, implementation and improvement of quality management systems along with providing quality auditing, supplier audit and training services. Our work provides the necessary information and useful insight to help you become a more profitable company through implementation of effective quality management principles that drive organizational health and effectiveness.
Quality Consulting Services Offered
Our team of experienced consultants have implemented numerous quality management systems for companies manufacturing a wide range of products including medical devices.
Our system has been proven to work efficiently and we have been through the process with many leading organizations due to which we are confident that you will pass in your first certification audit if you follow our plan.
Our consultants / project management team will work closely with you to ensure that your quality system is implemented on time and on budget. On-site training for your key employees in the concerned standard (s) is ideally included in your consulting cost.
Quality Management System Development / Implementation Services covering following standards / regulations:
We can assist you to develop your management system in a way to integrate all your systems and processes into one complete framework enabling your organization to maintain it effectively and efficiently.
We should be able to integrate your management system covering standards lime ISO 9001, ISO 13485, ISO 14001, OHSAS 18001, Canadian Medical Device Regulations, FDA’s QSR 820 and/or CE / MDD. Ask one of our expert regarding the advantage of this approach along with possible cost and benefit associated with it.
The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.” Contact us today to find out ways we could help you comply with the requirements....