Spin-off’s or start-up’s – especially within the medical device industry – can benefit from a standard set of QMS templates. These templates help to ensure a solid foundation upon which to base their quality management upon.
QMS templates provide the necessary baseline of QMS documents for the busy entrepreneur, to comply with both internal as well as external requirements. This ensures the right documentation is in hand, compliant, properly written and available for inspections or even, to be used for external development activities, where relevant.
Every template must be edited to reflect the company, their devices, classification, risk approach and much, much more. This job is made easier and more approachable by using the Pharma IT set of standard QMS templates for medical devices.
Pharma IT’s QMS templates come with a ready-to-use, pre-defined, compliant format and content, but are still flexible and possible to design to match the individual business. In this way, our QMS templates lower the barriers for spin-off or start-up companies to develop and remain compliant.
Each QMS template has built in support. This includes explanations and key questions to be answered in each paragraph, to ease this process for the user. Our templates also suggest a structured document management layout.
So, to be absolutely sure you have a compliant QMS, small companies should start with standard templates. To learn more – reach out to the Pharma IT Team.
