IVDT_In Vitro Diagnostics Technology

IVD Technology, November/December 2012

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IVD INSTRUMENTS method fi le. Th e entire information is protected from hack- ing or misuse by introducing the coded PLM name and/or the product name of a given assay. Before discussing the details of a modular OEM approach, it's important to clearly defi ne the competencies and responsibilities of the co-operating parties, i.e., the OEM and the PLM.2 1. Th e OEM is the company that produces the fi nished device for a private label manufacturer but does not market the device under its name. By contrast, the private label manufacturer is considered the legal manufacturer of the device under the terms of medical device regulations in general because the OEM product is marketed under the name of the private label manufacturer. 2. Th e private label manufacturer is the OEM's cus- tomer, who appears as the device manufacturer according to the Medical Device Directives (or legal manufacturer), but who doesn't produce the device itself. Th e project's organization follows the procedure shown Project Management for a Modular OEM Approach in the fl owchart (Figure 2). Prior to starting an OEM proj- ect, the customer's requirements are determined via a ques- tionnaire. Th e main issues for the customizing process are: 1. workfl ow, which is important for the graphical user interface; 2. detector confi guration; 3. corporate colors of the instrument's housing; 4. corporate logo on the instrument's housing and trans- port case. generated and loaded into the Lateral Flow Explorer soft- ware. Th e PLM has to decide if only part of the information or the entire method information should be coded into the bar code or RFID chip for further processing. Th e coded information will be available either on the outer box label or, alternatively, as a label located directly on the test cassette. Th e integrity of data transfer is protected by checksums. Th e PLM has full control of the lot-dependent assay ID 1. 1.1 Device Description 1.2 Product Specification 1.3 Reference to similar and previous generations of the device 2. Labeling 3. Design and Manufacturing Information 3.1 Device Design 3.2 Manufacturing Processes 3.3 Design and Manufacturing Sites 4. Essential Principles Checklist 5. Risk Analysis and Control Summary 6. Product Verification and Validation 6.1 General 6.2 Biocompatibility 6.3 Medicinal Substances 6.4 Biological Safety 6.5 Sterilization 6.6 Software Verification and Validation 6.7 Animal Studies 6.8 Clinical Evidence Table II. Types of technical documentation generated by the OEM. Th e product requirements and needs of the PLM are translated by the OEM into functional product specifi ca- tions. To ensure a streamlined and transparent project realization, it's essential to fully defi ne the customer's needs at all levels. Th e requirements are documented in the OEM Development Agreement appendix, which is signed by the OEM and the PLM. In addition, milestone meetings for review of the project's progress are scheduled. Several iterative cycles of development activities and cor- responding milestone reviews follow, leading to the realiza- tion of a prototype instrument that fulfi lls the customer's needs. Formal verifi cation of the prototype features against the customer's requirements is performed by the OEM; the results are documented and the prototype instrument is released. It's supplied to the PLM for subsequent validation under routine conditions for its intended application. Th e 32 IVD TECHNOLOGY | NOVEMBER/DECEMBER 2012 PLM is responsible for the validation processes; after suc- cessful validation, the prototype must be formally released in written form by the PLM for serial production. After the PLM releases the prototype, a Supply Agree- ment is established regulating all aspects of postdevelopment activities and serial production, such as lead times, pricing, warranty, (minimal) order volume, or servicing. A quality plan will be established at the request of the customer, which describes the rights and responsibilities of the OEM and PLM, especially if an IVD medical device is being devel- oped. Th e quality plan is of particular importance: it guaran- tees competent authorities or government agencies access to the technical documentation of the lateral fl ow reader that's protected by the OEM's intellectual property (IP). Regulatory Aspects Manufacturers of all classes of IVD medical devices must demonstrate conformity of the device with the "Essential Principles of Safety and Performance of Medical Devices." Technical documentation needs to be prepared that explains how the device's development, manufactur- ing, labeling, and marketing processes comply with these principles. Th e Global Harmonization Task Force (GHTF) pub- lished several guidelines aimed at establishing globally har- monized standards on: ivdtechnology.com Content Device Description and Product Specification, Including Variants and Accessories

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