TORONTO–(BUSINESS
WIRE)–CardioComm Solutions, Inc., received confirmation from the Canadian Medical Devices Conformity Assessment System
(CMDCAS) that it had cleared an ISO audit performed by DQS Medizinprodukte GmbH. CardioComm Solutions is
registered under Health Canadas
Therapeutic Products Programme (TPP) according to ISO 13485:2003 and CMDCAS as
well as MDD regulations, for the ‘Manufacturing and Distribution of Health
Management Software Systems and Distribution of Health Monitoring Devices. The
mission of the TPP, and the purpose of the audit, is to ensure that drugs,
medical devices, and other therapeutic products available in Canada are
safe, effective and of high quality.
The audit reported that management review, resource planning
processes and corrective action loops “are very well implemented” and that the
design and development process is “fully implemented and very well documented.”
In addition, the following responsibilities were audited: Production and
Process Controls; Customer Related Processes; Implementation of Applicable
Canadian Medical Devices Regulations, Part 1 Requirements; Implementation of
Regulatory Requirements of the Directive 93/42/EEC; and Document Control
Processes.
The audit concluded that the requirements of all applicable
ISO 13485:2003 standards as well as Canadian regulatory requirements are
fulfilled, that CardioComm Solutions quality system is well established and
that no non-conformities were found.
“This is excellent news for CardioComm Solutions,” stated
Etienne Grima, CardioComm Solutions CEO, “especially in light of the rally in
our stock price and brisk trading. The recent market response provides a clear
signal that our shareholders and corporate partners understand the significance
of the FDAs permission for CardioComm Solutions to sell the HeartCheck™ Pen
with our GEMS™ Home software. The results of this ISO audit demonstrate that
what differentiates CardioComm Solutions in the marketplace is our design
excellence and compliance pedigree as an ISO-certified, FDA-compliant software
engineering and solutions company.”
CardioComm Solutions achieved their first FDA clearance in
January 1999 and their GEMS™ software platform has been FDA cleared as a Class
II Medical Device since 2002.
“These 10-plus years operating in the highly regulated
medical software market has allowed us to become a trusted and preferred
provider in the prescribed ECG services market,” added Grima. “Our GEMS™ medial
customer base includes Toronto-based St. Michaels Hospital and the Hospital
for Sick Children, the Ottawa Heart Institute, the Calgary
Foothills Hospital
in Alberta, as well as US-based clients such
as the Mayo Clinic Health
System Hospitals
and Kaiser Permanente. Additionally, CardioComm Solutions has a customer
footprint covering more than 20 countries and has contractual relationships
with clients such as AstraZeneca, GE HealthCare and the Philips Remote Cardiac
Services.”
CardioComm Solutions is now preparing for its move into the
consumer medical market. “Our target is to reach the 3C market (Consumers with
Chronic Conditions),” explained Grima, “as well as those interested in primary
disease prevention. The HeartCheck™ Pen, together with GEMS Home and our C4
medical call service will serve to connect the 3C consumer to healthcare
practitioners using a solution that is globally expandable.”
“The FDA clearance was a material announcement and marks the
first phase of the pre-launch plans for the HeartCheck™ Pen distribution and
sales. Passing the 2012 ISO Audit confirms we are in excellent shape to proceed
to next steps, which will involve confirming sales channels and agency
representation across several global markets, finalizing technology
infrastructure for placement of multi-country C4 locations to honor the
requirements to house medical data in the country of service, and to confirm
production timelines,” stated Grima. “We have been on a progressive and
consistent path and believe that this is CardioComm Solutions time. It is our
2012 goal to connect consumers health in a way that has never been done before
– we are truly at the door step of exciting innovation and service.”
More Information
For more information on the Assessment Audit, the HeartCheck™ Pen or any
CardioComm Solutions product or service, call the sales and marketing group at
1-877-977-9425 toll free in the U.S. and Canada, or email sales@cardiocommsolutions.com.
About CardioComm Solutions, Inc.
CardioComms patented and proprietary technology is used in products for
recording, viewing, analyzing and storing electrocardiograms (ECGs) for
diagnosis and management of cardiac patients. Products are sold worldwide
through a combination of an external distribution network and a North
American-based sales team. The company has earned the ISO 13485 certification,
is HPB approved, HIPAA compliant, and has received FDA market clearance for its
software devices. CardioComm Solutions, Inc. is headquartered in Toronto, Canada,
with offices in Victoria,
B.C.
Posted by Sean Fenske, Editor-in-Chief, MDT
