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System Design and Development Support

Our staff can:

  • Lead your team in the creation of the overall system risk analysis and development of system level safety requirements

  • Review existing system risk analysis, safety requirements, and Use Error analysis

  • Review architecture and make recommendations for safety and segregation arguments for risk control, safety assurance cases, and proper allocation of risk to software.

Electrical Product Safety, Review, Pre-Testing, and Submissions

Our staff can assist you by providing a variety of electrical product safety services to help you comply with the various electrical safety requirements such as the IEC/UL/CSA versions of 60601-1, 60950-1, 61010-1 and the related particular standards including EMC. By working directly with test agencies such as UL, CSA, Intertek, TUV, SGS, and other NB/NRTL's, we are able to interpret the standards for you and prepare the paperwork. We can preview your product for potential problems and recommend compliant design solutions before you submit to the certification agency. We can also pre-screen your product by conducting the following tests: HIPOT, Insulation Resistance, Leakage Current, Ground Continuity, and very rough emissions near-field scans.

EMI/EMC Design, Lab Selection, and Test Support

Our staff can help with the selection and management of your test labs. We have many years experience with best practices in preparation, day-of, and test follow-up.

Wireless Coexistence Testing

The FDA guidance document "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" (2013, section 3-c) sets the expectation for wireless coexistence testing. The primary concern for safety is that many clinical environments already have existing wireless networks in the 2.4 GHz band (and now other bands) and these multiple networks are competing for the same region of the band. While WIFI and Bluetooth technologies are designed to coexist, that only works up until a certain point. Further, there may be 2.4 GHz devices in the clinical area that do not coexist very nicely, e.g., portable telephones.
We can help our clients design a suitable test that considers FDA expectations and new standards for this type of testing. We can then support testing in our clients' labs or in our test facilites. We can help our clients show compliance to IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence and to AAMI TIR69: 2017 Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.

Product Marking / Labeling Requirements

We can help navigate the many product marking requirements from the standards as well as FDA expectations. We can also design and manage usability evaluations of labeling and/or marking.

Technical Writing

We have many years experience at assisting with writing technical documentation that fulfills the standards and meets usability principles.

Notified Body Selection and CE Marking Regulations

We can assist with NB selection, communication support to NBs, assistance with surveillance audits, and product review issues.

Contact Us

T: (813) 766-0563