Friday, August 31, 2012

What do ISO, AGD, and Health Canada certifications mean to you?

ClearDent's ISO13485:2003 Certificate
Organizations that provide solutions to dental professionals, such as ClearDent, have an obligation and responsibility to provide the highest level of quality management and assurance to its customers. After all, defective dental software or inadequate services have the potential to hinder a dentist’s ability to provide proper patient oral healthcare, or in the worst case can cause injuries.

There is usually some ambiguity surrounding the veracity of a vendor’s claim of quality. Therefore, in an effort to achieve transparency and also to comply with government regulations, ClearDent has committed itself to go through and obtain the following certifications:

International Standard Organization (ISO)

ClearDent has received the ISO13485:2003 standard certification. The standard applies to the design and development, implementation, and support of dental office patient data management software. To put the effect of this certification into practice, let’s look at the digital x-ray – one of the many functions that ClearDent provides. With this certification, it can be said that ClearDent is able to produce a high-quality, diagnosable digital x-ray image shot after shot under normal operations. As an added benefit, should there be other factors affecting the normal operation or preventing ClearDent from being able to deliver high-quality, diagnosable digital x-ray images, the ISO auditor has observed adequate implementation and support process to indicate that ClearDent is able to determine the root cause and advise its customers on how these adverse factors can be addressed in a timely manner (i.e., a proper resolution to a support call). Better yet, ClearDent has subjected not just its digital x-ray and imaging functions for the certification, but the entire system, which includes functions such as electronic charting, document management, scheduling, financials, patient data management and protection (including privacy compliance). It is truly the highest standard of certification that a dental software company can achieve in Canada presently.

Further, the certification also requires ClearDent to establish and track its quality standards, such as the minimum live answer rate and response time. As many of our existing customers can attest, support calls to ClearDent are answered timely and the technicians are professional, courteous, and resolve reported issues quickly.

Click here or on the certification mark above to see an electronic copy of ClearDent’s certificate.

Health Canada Medical Device Class II License

As software is considered a medical device, it’s regulated by Health Canada. Practice management software systems are often considered as Class I and ClearDent could very well be a Class I device. It would have been easier for ClearDent as the requirement for obtaining a Class I device license is comparatively less stringent than higher classes. ISO13485:2003 certification is a prerequisite in obtaining a Class II license, but having the said ISO certificate does not automatically qualify the dental software to be a Class II device. To qualify, the software must meet the following criteria per Health Canada regulation:
  1. Provides the only means and opportunity to capture or acquire data from a medical device for aiding directly in diagnosis or treatment of a patient.
  2. Replaces a diagnostic or treatment decision made by a physician.
  3. Has the capability in data manipulation, data analysis, data editing, image generation, recording of measurements, graphing / charting, flagging of results or performing calculations
In other words, after consultation with Health Canada, it was shown that ClearDent is a Class II device because ClearDent becomes the only means for dentists to do their work efficiently. Therefore, Health Canada regulates ClearDent as a Class II device. Having a quality management certification from a fully independent and Health Canada recognized auditor in order for ClearDent to receive our Class II license implies it’s absolutely safe to go paperless with ClearDent.

Click here to view ClearDent's Health Canada Medical Device Class II License on Health Canada's website (search by "Device Name" and enter "ClearDent" in the search field).  You can also search to see if the software you are currently using is a Class I or a Class II device on the same site.  NOTE: a dental software system must have at least a Class I license.

Academy of General Dentistry (AGD) Program Approval for Continuing Education (PACE)

ClearDent's AGD PACE LogoMost dental colleges recognize practice management as a valid topic in dental professional’s continuing education effort. However, there is again some ambiguity surrounding the quality of training and education on this topic as there is not a universal standard to verify course content and materials covered as with most clinical courses.

ClearDent wants to ensure our delivery of education in practice management, including the use of the system to manage a practice and go paperless, is of the highest quality. Thus, we have applied for AGD PACE.

There are specific criteria and requirements in becoming an approved PACE provider. The guideline is available here but in a nutshell, it means ClearDent will always deliver our courses, whether information sessions for prospective customers or in-depth training sessions for its current customers, by firstly disclosing any of its commercial interests before course content delivery. It is also required that ClearDent ensure its actual course content free of any “buy” trap. This means when you attend an information session, a seminar, or receive a training session from ClearDent, not only they are always free of any “selling” during the actual presentation, but ClearDent has a clear mandate stated as required by PACE to deliver the content specific and relevant to its course title at all time. There are also satisfaction tracking requirements to ensure our courses are of high quality.

Click here or the AGD logo above to see ClearDent’s PACE certification.