Capsule's Commitment to Quality

Capsule is a company 100% committed to quality.  Our solution is ISO-13485 certified ensuring that we have effective and established quality and risk management procedures in place.  It is also one of the first in the industry to be FDA 510k cleared, and is actually cleared as a Class II medical device. We sought out this 510k clearance from the start, well before MDDS was even proposed by the FDA because we are, and will always be, commited to developing safe and effective solutions.  And while there have been those in the industry that claim MDDS' don't need Class II regulatory clearance, we believe that it is the only way to ensure protection as connectivity solutions evolve.

As the leading provider of device connectivity, we are looking towards the future of connectivity, beyond just connecting device to systems. We understand where connectivity needs to go. We know that it is evolving and we are therefore working with our customers and partners to develop the connectivity solutions of tomorrow that hospitals need. Our roadmap includes solutions that will enable an optimized workflow and address the challenges of managing association at the bedside. These types of solutions will require Class II FDA clearance as well as an established quality and risk management system.

And, quite frankly our partners and most hospitals we work with demand this level of clearance because they don’t want to bear the risk of not having a fully regulated solution that offers the most protection possible. So if you want the safest and most effective solution today and tomorrow, then your only choice is Capsule. Why? because Capsule knows what it takes to connect.

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