High Performance. Mobile. Medical Device Applications.
Medical device companies continue to adjust to heightened standardization and regulatory concerns from the FDA, in addition to ever-increasing expectations and demands for higher quality from the medical community and consumers.
As a result, these companies are searching for reliable external support from service providers that can demonstrate technology alignment and regulatory compliance expertise, and drive the quality results they need. They are searching for Performance.
At Performance, we understand and appreciate the pressures affecting the medical device market and our safety-critical clients. We are experienced in navigating the complexities and nuances of federally regulated industries and high performance solutions. Additionally, we are committed to advancing high quality software through the unified front of mobile applications.
We view our clients as partners and we are passionate about helping them achieve success in projects large and small. We take pride in applying our skills and expertise in regulated-software development to help them overcome their challenges, achieve their goals on time and on budget, and drive best-in-class medical device performance.
Proven Domain Expertise
For more than 15 years, Performance has worked closely with leading medical device companies. We understand the sensitivities and complexities of their projects and the associated FDA regulations and requirements. In all cases, we have proven our skills and expertise, and our ability to meet rigorous standards and processes in these core medical domains.
- Next Generation Computed
- Tomography (CT) Scanner
- Advanced Technology Mobile
- Real-Time patient monitory devices
- Patient Record Management
- Billing and Reporting
EMR and PACS Interface and Connectivity
- DICOM, HL7, IHE, SCP
- Stress Testing ECG
- Resting ECG
- Ambulatory Blood Pressure
- Cardiology Rehab
Technology. Process. Standards.
Our zealous commitment to client satisfaction is what drives our organization to develop our abilities and expertise to the fullest. To this end, the Performance team has achieved, and continuously demonstrates, comprehensive knowledge of a wide range of hardware devices, operating systems, and development environments as well as the ability to support full lifecycle software development or address targeted aspects of projects on Class I, II, and III medical devices.
Functional expertise includes but is not limited to:
- Soft Real-Time PC-based medical instruments
- Windows-based platforms: Server editions, XP, Vista, Windows7, Windows8
- Real-Time embedded medical instruments
- RTOS platforms: VxWorks, VRTX, QNX, pSOS, Win CE
- Mobile application development
- Model-based design
- IBM Rational Rhapsody
- Practical application of Cloud-Based Services
- Extensive FDA experience with clinical trials, 510K, PMA and IRB processes
- Medical Device Development and Quality Standards
- IEC60601, IEC62304, IEC80002
- ISO14971 and ISO9001 for Class II and Class III devices
- Human Factors Engineering for the design of medical devices (ANSI/AAMI HE75:2007)
- Risk management for IT-networks incorporating medical devices (IEC80001)
Our proven experience, expertise, reliability and performance in these areas have been critical factors in solidifying our role as a Preferred Supplier and preferred partner for top-tier medical device suppliers.