You Need Expertise. We’ve Got It.
For optimizing cost, accelerating time to market, and ensuring best-in-class quality, partner with i3 infotek. Start by choosing i3 infotek’s deep technology and engineering R&D skills. Create a competitive edge with our medical device consulting expertise for the long or short term.
Your Goal Is A Successful Medical Device Launch. So Is Ours
i3 infotek professionals work to ensure your medical device and its packaging system meet all FDA, EC, Health Canada, and ISO requirements. We have every kind of industry-dedicated engineering professional at your service from day one through the life cycle of your device.
You Need Confidence In Quality. We Deliver It.
While capturing first-mover advantage is vital, it is easy to underestimate the value of embedded quality systems. Defending against the relentless competition and remaining flexible on pricing economics may take away attention from your product’s quality. This may prove costly in the long run. Trust i3 infotek’s domain competence in medical devices to help you avoid pitfalls or make course corrections to deliver superior product quality.
Risk management governs the entire life cycle of a medical device. ISO 14971 guides what medical device manufacturers must do to protect against safety risks. i3 infotek consultants free up your time for device development efforts while we manage ISO compliance.
We have assisted global medical device leaders in deploying comprehensive risk management programs. Our professionals bolster your confidence in the chosen strategy by identifying potential hazards, establishing associated risks, and creating responsive processes.
Having engaged with complex operations across Fortune 500 companies, we are privileged to have encountered every possible pitfall during medical device development. Working with i3 infotek empowers you toward the validations that get your product to market. This expertise guides you to identify vulnerabilities in design and production plans.
Seize the expert advantage during the R&D phase. We can join your teams anytime, but early intervention undoubtedly saves time, money, and regulatory denials.
i3 infotek consultants are experts in ISO 13485 compliance. Clients rely on us to simplify complex matters of emerging regulatory compliance. Regarding scrutiny issues, you can unburden your in-house team to track and implement revised standards. You can count on i3 infotek teams to transform your investments into outcomes cost-effectively.
Does your quality management system comply with ISO 13485:2016 updates? QMS and other areas of compliance have changed. The new version affects new and renewing certifications. Partnering with i3 infotek consultants is to invest in certainty and peace of mind.
The ISO 13485:2016 transition changed the requirements of the standard. Are your operations compliant with the changes? Our consultants can analyze your development activities and manufacturing validations for ongoing audit approvals.