Tracelogix Inc.

Quality Policy

“Tracelogix is committed to meeting or exceeding the needs and expectations of technology companies with respect to hardware repair and related services.”

Tracelogix objective is to become the vendor of choice in the market for technology/electronics companies by meeting and exceeding our customer’s expectations with respect to hardware repairs and services.

Tracelogix will:

- continually improve quality and reliability of our services
- will apply innovative services approach
- will develop our expertise of market’s requirements

Tracelogix means of achieving objectives are:

- to maintain and develop relations with our customers
- to develop a partnership with customers by understanding their needs and expectations
- to developing internal organization by providing appropriate training and resources to achieve targets
- to continually monitor our performances and customers’ satisfaction

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Health Canada Medical Device Establishment License (MDEL)

Class 1 medical device manufacturers must secure a Medical Device Establishment License (MDEL) if selling direct and not through a distributor. If you sell through distributors in Canada, and the distributor already has a Medical Device Establishment Licence, you do not need one. Class II,III and IV manufacturers do not require an MDEL. Health Canada Medical Device License (MDL) The Canadian Medical Device License (MDL) is required for companies which sell Class II, III, and IV medical devices in Canada. The MDL is a product approval and should not be confused with the MDEL which is a permit for the company/distributor itself. Canada's Medical Device License (MDL) is comparable to the US FDA 510(k) process, except the process of securing a MDL is usually faster for Class II devices, about the same for Class III devices and more complicated for Class IV devices.

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21 CFR Part 820

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in § 820.30(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subject to part 606 of this chapter. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in §1271.3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.

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Tracelogix Corporation Quality Policy

Tracelogix Corporation is committed to meeting or exceeding the needs and expectations of technology companies with respect to hardware repair and related services and to comply with and continually improve the Quality Management System.

Our Quality Management System will:

• Comply with standard ISO 9001:2000, 21CFR820, and applicable statutory and regulatory requirements;
  

  Tracelogix Corporation Objectives

We will achieve our objective by:

• Maintaining close relationships with our customers;
• Understanding their requirements;


• Allocating sufficiently qualified and trained human resources to perform their assigned tasks; and


• Measuring and monitoring our performance.

Our objective is to become the vendor of choice in the market we service because of:

• The quality and reliability of our services;
• Our offering of innovative products and services; and


• Our understanding of the market’s requirements.

Tracelogix Corporation Measurable Objectives

• Warranties (second returns) should be less than 3%
• Turnaround time should be 5 business days or less from dock-to-stock (excluding awaiting test equipment/parts ordered and awaiting disposition from customers).
  

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ESD Safe Handling

Tracelogix adheres to all ESD safe handling practices. Our technical staff is trained and certified to comply with all ESD standards.

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