Quality system development is the most critical initial and ongoing activity for the firm. Robust quality system development will ensure long-term compliance and viability.
 
 
Once established, a company’s Quality Management System involves all parts of the business. As such, ongoing success depends upon proper quality system design, documentation, implementation, maintenance and ongoing development. In a well-managed QMS, the ‘quality culture’ should drive all aspects of the business, with the aim of achieving long term success.
 
In addition to helping with the initial QMS implementation, GEMAR can assist with ‘fine tuning’ your processes and metrics to keep pace with company expansion, including entering new markets with different regulatory requirements, including Medical Device Single Audit Program (MDSAP) requirements, or the manufacture of products falling under higher risk classifications. 
 
GEMAR recognizes that ongoing quality system development is an important business activity as well as being essential to regulatory compliance, and can help to ensure continued competitiveness and market viability. 
 
GEMAR will assist you along every step of the development process, from the decision on your suite of regulations and standards to the certification or approval audit events through quality system maintenance and gap analysis in support of new requirements identification. Contact us to learn more.