Most internal groups have some quality system in place, but they’re their own systems, set with their own arbitrary, internal standards.
Our ISO 13485 certification ensure consistent use of processes and quality management principles that were developed over decades and have become the gold standard in operational quality.
Those Principles Include:
The True Process ISO 13485 certified services are repeatable, consistent and proven, so your products consistently meet your customers’ requirements.
There are no “mostlys” in compliance. It’s mandated. And with patient safety, clinical outcomes and costs at stake, it’s no wonder.
But with over 400 federal agencies that regulate healthcare, and an astronomical number of requirements and regulations, the depth and consistency of compliance knowledge is challenging for many medical device and healthcare information technology organizations.
Since True Process develops our own medical device connectivity and patient bedside point-of-care products, our compliance domain knowledge is a requirement of our business well as yours. Regardless of the type of work we provide for our clients, it is always with an eye towards compliance.
Only those data systems consultant who are not highly experienced in healthcare believe that “Data is data, It just needs to get from once place to another.” Healthcare workflow data is distinctly different.
Our clinical expertise comes from years of working with medical device manufacturers and their implementation teams, and the clinicians who use them. Science and art.
Our work is in over 500 healthcare facilities in the U.S. and throughout the world.
Why service, support and professional services need True Process.
True Process Product Development Methodologies and Factors Include:
These, and many more factors, are part of our 10,000 foot to one micrometer produces we use in partnering with our clients to enhance legacy products or design and develop for their future portfolios.
There are intricacies and nuances involved in orchestrating and delivering data for real-time clinical decision making.
We’re experienced with the core technologies involved in bedside care and the centralized IT system that utilize the data.
We can ensure that your medical device and software is optimized for your clinical customer, whether we’re involved in healthcare product development or assist you in the field with medical device connectivity, medical device integration, or medication administration solutions.
Data separation among medical devices has been replaced with medical and healthcare information systems that require thoughtful planning of what, when, where and how the medical devices’ data will be integrated. Medical device integration and connectivity is critically important.
The velocity of healthcare reform has required medical device and healthcare information technology companies to plan, design, supply, manufacture and support their medical products in new ways, often with unrealistic deadlines.
For a medical or healthcare organization focused on single solution products, it’s a daunting position. It means warp-speeding all aspects of your medical product life-cycle, possibly with the experience, competencies or bench depth required to stay ahead of your competitive market.
True Process develops, manages and implements medical devices and medication administration software so that our clients can focus on their own core business objectives. True Process also has deep expertise in Bar Code Medication Administration - BCMA as well as Real Time Location System solutions - RTLS. Healthcare workflow and medical workflow is our true passion.
Unlike typical engineering or IT staffing groups, our healthcare and medical service solutions have the insight and experience of three important disciplines: engineering, IT and clinical.
Creativity and innovation. Big important words when you have a challenge, a deadline and a lot is at stake. It’s our clients who have told us that we don’t look at a job order; we look at a problem that needs a solution. Talk to True Process about our expertise in medical device connectivity, medical device integration, medication administration and medical workflow.
We believe that there is always a bigger picture, and that our work begins with what you need to accomplish rather than what needs to be done.
At True Process, we ponder multiple ways to provide the solution, leveraging that latest technologies in the medical and healthcare fields, best practices and novel ideas.