Medical Device

You Need Expertise. We've Got It.

Simply put, I3 Infotek delivers the medical device consulting expertise you need, for the long or short term. We can help you get new devices to market faster, ensure quality and realize cost savings.  Your business benefits from enlisting the right engineers and experts from the start. Many disciplines are critical to the sustainable success of your device. We have experts in all of them.

Your Goal Is A Successful Medical Device Launch. So Is Ours

Our professionals work to ensure that that your medical device and its packaging system meet all FDA, EC, Health Canada and ISO requirements. We have every kind of industry-dedicated engineering candidates at your service from day one through the life cycle of your device.

You Need Confidence In Quality. We Deliver It.

Processes and quality systems can seem less urgent than the actual device. It is easy to underestimate the value of quality systems. Relying on "just what you need" to pass a single compliance audit may achieve a momentary green light, but can lead to problems down the road. We can help you avoid pitfalls or get back on track.

How We Can Help

ISO 14971 Support

While risk analysts can benefit the process at any stage, teaming I3 Infotek analysts with your R&D from the early stages can save significant resources down the road. We help get your device to market faster.

ISO 13485 Support

The ISO 13485:2016 standards are under way. It is important that your medical device quality management system and processes maintain compliance. Are you knowledgeable on what has changed? Our consultants are up-to-the-minute with ISO, EU and HC requirements.

Supplier Quality Engineering

We come to you, bringing at-the-elbow supplier quality experts and technical leaders for on-site medical device manufacturing engineering support.

Postmarket Surveillance

When the launch is over, the work continues. In fact, maintaining your hard-earned position in the market depends on staying ahead of every change in your manufacturing and sourcing processes.

Manufacturing Engineering

Finally, your medical device design is complete and proven. it’s time to manufacture it for the world. Your launch is only as successful as the precision of the equipment and qualifications of the partner who will manufacture it. Leave nothing to chance.