At ZIEN, we are committed to helping you launch your product. As a medical device ‘Integrator’, ZIEN Medical provides the product development, resourcing, quality systems, manufacturing, packaging, sterilization, and regulatory expertise to facilitate rapid product development and navigate this heavily regulated industry. With these resources ZIEN acts as an integrator providing the ability for startup companies to rapidly secure the infrastructure required to launch a device without the expense of brick and mortar investments, and the time and expense of locating and hiring your own team. With an existing team and infrastructure ZIEN can immediately begin the product development process which results in a reduced cost and significant reduction in time to commercialization for new products. This results in up to 70% savings over traditional medical device product development, and often 12 months or more savings in time to market.  

As the global regulatory environment continues to increase in the rigor required for medical device development and manufacturing, the need for a highly sophisticated quality system and experienced team is growing beyond what previously was sufficient. In this new world smaller companies are at a distinct disadvantage in trying to achieve regulatory clearance on their products. This is where ZIEN can make the difference between success and failure. Trying to develop a product is hard enough without having to also achieve ISO13485 certification or maintain FDA 21CFR compliance. And purchasing a ‘canned’ or SAAS QMS can help you with the basics, but doesn’t prevent the need to hire the resources necessary to spend the months of work to operate that system to a level that will achieve audit readiness.  The implementation of the EU MDR has made accessing the global market expensive, complex, and time consuming.  

By operating as the ‘Manufacturer of Record’ for our customer’s products, ZIEN helps entrepreneurs and startups alike streamline or leapfrog the product development and regulatory process to get to market fast. Once again the global market is accessible! We can help from concept to global launch. Let us show you what we can do to help commercialize your product worldwide.