JTECH Medical's Regulatory Certifications

JTECH Medical Industries, Inc., a medical device company developing innovative, next-generation therapeutic and evaluation products, is certified to ISO 13485:2003 with CMDCAS and ISO 9001:2008. JTECH has also received, a Device Establishment License to distribute our products throughout Canada and is registered with the FDA.

Commenting on JTECH's Certifications, Len Smith, President of JTECH Medical, said, "Achieving CMDCAS certification is a further endorsement of JTECH's manufacturing capabilities and approach to quality system management. This has enabled us to move forward with the registration and commercialization of our products in Canada.  We plan to aggressively promote and market our products in Canada immediately. Being certified to the ISO 9001:2008 standard in our manufacturing facility emphasizes our commitment to maintaining and improving the quality of our products, manufacturing processes and communications with our customers. This commitment and certification allows us to move closer to our goal of providing the highest quality therapeutic and evaluation products,"

The ISO 9001:2008 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. The ISO 9001 standard provides a tried and tested framework for taking a systematic approach to managing an organization's processes so that it consistently turns out products that satisfy customer expectations and can assure regulatory authorities that JTECH Medical is manufacturing products using a quality management system in its facility. 

The ISO 13485:2003 standard is an international reference standard for the evaluation of quality management systems for the medical industry. The standard refers to an organization's structure for managing its processes or activities that transform inputs of resources into a product or service to meet customized objectives, such as satisfying customer quality requirements.

Compliance to ISO standards are certified by third-party audit and registration organizations.

JTECH Medical devices also meet the following Technical Standards, to which Conformity is declared:

ISO 9001:2008
ISO 13485:2003 with Canadian Medical Devices Conformity Assessment System (CMDCAS)
Safety and EMC requirements for medical electrical systems (based on the IEC 60601-1 and IEC 60601-1-2 standards)
CB Scheme Test Certificate has been issued for the Tracker Freedom System indicating conformity to IEC 60601-1 +Amd1+Amd2 2nd edition (Note: the Tracker Freedom Wireless Heart Rate Monitor and the Wireless Algometry Hand End-Test Switch are excluded from the CB Scheme Test Certificate)

Wireless information

The Commander Echo Console and devices transmit in a 2.4GHz wireless frequency.
Contains Model XBee-Radio, Canada IC: 4214A-XBEE
Japan ID: 005NYCA0378

The Tracker Freedom devices operate on a 902-928 MHz (US) or 868-869.3 MHz (EU)wireless
Contains FCC ID: SNU-8CB001
Contains Canada IC: 5478A-ACD001

JTECH Medical devices complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (i) this device may not cause harmful interference and (ii) this device must accept any interference received, including interference that may cause undesired operation. 

JTECH Medical and its manufacturing facility are certified to the following technical standards.

ISO 9001:2008
ISO 13485:2003 with Canadian Medical Devices Conformity Assessment System (CMDCAS)

Below is a list of JTECH's Certifications:

ISO 13485:2003 CMDCAS Certificate
ISO 9001:2008 Certificate
Tracker Freedom CB Certificate - IEC 60601-1

FDA information

JTECH Registration Info -http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=74324
CAT Info -http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=133724&lpcd=LXM
Dynamometer Info -http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=133725&lpcd=HRW
Goniometer Info -http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=133726&lpcd=KQX

Canada and EU information

Canadian Medical Device Establishment License
Canadian Medical Device License for Kits
Canadian Medical Device License for Physical Evaluation and Testing Products
Canadian Medical Device License for Software
EU Rep

Declaration of Conformity

JTECH Medical instruments are Class I medical devices per Annex IX of Council Directive 93/42/EEC and CFR Title 21 Part 888 Subpart B.
All JTECH Medical devices are CE marked

Cleaning, Disinfection, and Sterilization for JTECH Medical Devices

Warning: Keep dry, do not immerse any part of any JTECH Medical device, or accessory in water or any other fluid.

JTECH Medical Devices and accessories are non-sterile devices and are not compatible with sterilization techniques such as autoclave.
Do not autoclave JTECH Medical Devices or accessories.
Do not clean with abrasive materials.
Do not clean with solvents, or disinfectant not approved by JTECH Medical.

Recommended Cleaning of JTECH Medical Devices and accessories
Wipe surfaces with a soft, damp cloth and mild soap. Remove any soap residue with a clean, non-abrasive cloth dampened with clean water.

Recommended Alternative Method for Cleaning JTECH Medical Devices and accessories.
CaviWipes disinfecting towelette. Use only as directed, following all instructions and warnings on the CaviWipes packaging.
Warning: Follow all directions as specified by the CaviWipe product being used. Allow devices to dry before use.

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