Medical devices are required to show they perform safely and effectively. Depending on the type and classification of device, certified safety testing at a third-party test lab may be required prior to receiving FDA clearance and regulatory approval. FDA recognizes the International Electrotechnical Commission (IEC) and ISO standards. Many companies lack the time and knowledge to successfully get their devices through this process without many painful hurdles, which in turn can cause delays with regulatory clearances, thus impacting speed to market.
Is your company ready to have your device tested, but you don’t know where to start? Has your product already been tested and failed testing?
Our experienced team offers over 25 years experience supporting medical devices through certified safety testing. Qualitas treats your device as our own and handles the device through every stage of testing to help guide you through the process. Qualitas can provide the following testing services:
- Recommend and assist with the test lab selection process
- Educate your team on the ins and outs of the safety testing process
- Identify device essential performance
- Establish EMC Test plans and documentation needed for safety testing
- Conduct a device compliance review to show potential testing failures prior to going to the test lab
- Generate study reports for risk mitigation and risk management file
- Assist with documentation needed for testing and participate in documentation reviews onsite at the test lab
- Complete TRF checklists with supportive documentation
- Establish a trace matrix for your product
- Review your product’s IFU for the required electromagnetic warnings / cautions per the standards tested
- Take your device onsite to the test lab to walk it through testing and act as a Subject Matter Expert to interpret the standards and be an advocate for your company during the testing process
- Help to expedite testing schedules
Qualitas has successfully supported our clients through safety testing for certification and provides total quality assurance through the medical device product lifecycle.
See below for a partial listing of standards that Qualitas can help support your testing efforts:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-1-11
- IEC 60601-2-10
- IEC 60601-2-24
- IEC 60601-2-50
- IEC 60825-1
- IEC 62366
- IEC 62304
- ISO 14971
- ISO 80601-2-67
Please visit our standards page for additional standards that we support.