Medical device manufacturers must often conduct post-market clinical investigations to collect additional information about a product already approved for sale. These clinical trials are often required of manufacturers making specific medical devices such as pedicle screws for spinal surgery, or a specific application of the devices (example: all devices also used for pediatric applications). Emergo's global consulting offices can assist with planning, conducting and monitoring post-market surveillance clinical trials for medical devices.
Post-market clinical investigations may be required to measure:
- Residual risk of a medical device that IS used properly according to labeling.
- Long term performance and impact of the medical device, especially if new materials or technology are used.
- Events that are specific to defined population groups.
- Performance of the medical device in a more representative of the population.
Post-market clinical trials for medical devices may also be required if...
- New indication for use or claim has been approved.
- Significant changes have been made to the medical device or labeling.
- Risk classification of the device has been increased.
- Post-market surveillance activities have raised questions about safety or effectiveness.
- Unanswered questions regarding long term safety or performance, or risks already identified from other similar devices.
- On request from CMS, FDA and/or medical community leaders.
Regardless of the reason you need to conduct a post-market clinical investigation, Emergo's clinical consulting team can help you clearly define the objective of your post-market clinical study, design the study, create a protocol, implement the study and analyze the data. Depending on your needs, we may perform a new post-market study, an extended follow up of patients involved in your premarket investigation (if applicable), or a review of data taken from a device registry or from patients previously exposed to the medical device.
Global offices and a focus on medical devices
Emergo has in-house clinical consulting teams located in the UK, France, Germany, The Netherlands, Russia, Japan, China, India, Australia, Brazil, Mexico, Canada and the USA. We maintain regulatory and clinical consulting offices globally, but we are not a giant clinical company that focuses on pharmaceuticals. We only serve the medical device industry and therefore offer highly personal service with a focus on completing projects quickly and cost-effectively.
Please contact us for additional information on our post-market clinical investigation consulting services.