Document Control Medical Devices

CryoConcepts is a company that manufactures cryosurgical devices under the guidance of FDA and ISO regulations for use by health care professionals. Because of the company structure where employees are decentralized with some located in other countries, a brick and mortar approach to the Quality System Documentation Control would have been difficult to implement and maintain. With that in mind, an internet-based cloud approach to a shared system was adopted early as one of the company’s philosophies.

 Having BizzMine provide support for the Quality System infrastructure has freed us up to concentrate on growing the business.

The Document Control Module is a perfect fit for ours needs. Early in the life of CryoConcepts, we implemented the Document Control Module to support the structure for our Quality Management System. It houses our quality system documents and design files.

We make extensive use of the change control and revision tracking capabilities already built into the system. Use of the Document Control Module has streamlined our document assessment, approval and publication processes providing our employees secure access over the internet enabling us to put the most current documents into effect quickly and efficiently.

Another valuable aspect of the Document Control Module is that a computer with internet access is all that is needed to implement and access the system. BizzMine takes care of the rest. We did not have the upfront capital costs of hardware (servers, routers, etc) nor software. We’ve also saved on personnel costs by teaming with BizzMine. They take care of the day-to-day tasks of help desk, system maintenance, backups, disaster recovery preparedness, etc.

As an early stage company, our employees wear multiple hats.


Larry Fishler, Director of Operations