Insights for FDA Regulated and HIPAA Compliant Organizations
Bringing Products to Market in a Global Regulated Environment
The rapid pace of process innovation and technological advancement in the last decade has introduced both significant benefits as well as significant challenges to FDA regulated industries. Learn More about TAGmedica
Companies these days are faced with demands of bringing products to market faster and faster, not only to meet sales and market demands, but also to ensure they are not outpaced by the fierce competition.
Today's competition is global and diagnostic and genetic testing companies face competition from upstarts around the globe, as well as large companies that have vast resources at their disposal.
Any company can very easily discover that it was just outpaced by a competitor. In fact, you could discover overnight that your company has been eclipsed by a competitor which has a larger sales team pushing its technologically advanced product. Scary thought.
To makes things even tougher, no matter what type of test or screening an organization builds, the quality cannot be compromised. To ensure that quality remains top notch, compliance standards must be maintained and validated. In effect, this also can limit a company's ability to move and react quickly.
All clients of TAGmedica leverage the power of our ISO 13485 quality standards to secure the best prices, quality and lead times for materials such as packaging, kitting and printing.
Getting to market fast requires planning, flexibility, and the ability to react rapidly in the face of newly discovered challenges. Maintaining quality, on the other hand, requires adherence to strict rules and proper management of records.
We are in an era where advancement of technology combined with the maturity of organizational mind set will enable any size businesses to compete globally—and win. With today's technology, applications are coming to market that provide companies with a wide spectrum of capabilities combined with amazing ease of use and very affordable prices.
When it comes to organizational mind set, companies today understand the urgent need to move fast and stay compliant and it is becoming clear that the only way to move fast, react fast and win is to stay ahead of the pack in both technology and internal processes and procedures.
Systems that enable flexibility and provide value to users are now welcomed inside all companies.