ࡱ> M lbjbj== XWWelxxxxxxx$<2<2<2P22I*x4x4(444444(I*I*I*I*I*I*I$J LzNIx44444NIr5xx44cIr5r5r54x4x4(Ir54(Ir5 r5>xx>4l4 /<24:>>4 yI0I>mM4mM>r5xxxx Manufacturers Name: Device Group / Family: Device Type / Product Code: Classification: Completed by: Date: PRINT: Reviewed by: Date: PRINT: Approved / Issued by: Date: PRINT: Revision: Original  I. GENERAL REQUIREMENTS 1. The device must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. 2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: -eliminate or reduce risks as far as possible (inherently safe design and construction) -where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, -inform users of the residual risks due to any shortcomings of the protection methods adopted.3. The devices must achieve the performance intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1(2) (a) as specified by the manufacturer.4. The characteristics and performances referred to in sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical condition and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.5. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.6. Any undesirable side effects must constitute an acceptable risk when weighed against the performances intended.II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 7. Chemical, physical and biological properties 7.1 The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the "General requirements". Particular attention must be paid to: -the choice of materials used, particularly as regards toxicity and, where appropriate flammability; -the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device;7.2 The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and the duration and frequency of the exposure.7.3 The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during normal use or during routine procedures; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance with the intended use. 7.4 Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in Directive 75/318/EEC.7.5 The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device.7.6 The devices must be designed and manufactured in such a way as to reduce as much as possible, risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.8. Infection and microbial contamination 8.1. The devices and their manufacturing processes must be designed in such a way as to eliminate or reduce as far as is possible the risk of infection to the patient, user and third parties. the design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use.8.2 Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues. Notified Bodies shall retain information on the geographical origin of the animals. Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses and other transferable agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.8.3 Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened.8.4 Devices delivered in a sterile state must have been manufactured and sterilised by an appropriate, validated method.8.5 Devices intended to be sterilised must be manufactured in appropriately controlled (e.g. environmental) conditions.8.6 Packaging systems for non-sterile devices must keep the product without deterioration in the level of cleanliness stipulated and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination. The packaging system must be suitable taking account of the method of sterilisation indicated by the manufacturer.8.7 The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition.9. Construction and environmental properties 9.1 If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label or in the instruction for use. 9.2 Devices must be designed and manufactured in such a way as to remove or minimize as far as possible: - the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional, and where appropriate the ergonomic features, - risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and acceleration, - the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given, - risks arising where maintenance or calibration are not possible (as with implants) from ageing of the materials used or loss of accuracy of any measuring or control mechanism.9.3 Devices must be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substance which could cause combustion.10. Devices with a measuring function. 10.1. Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.10.2 The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.10.3 The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC, as last amended by Directive 89/617/EEC.11. Protection against radiation 11.1 General 11.1.1 Devices shall be designed and manufacturer such that exposure of patients, users and other persons to radiation shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.11.2 Intended radiation 11.2.1 Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters.11.2.2 Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such emissions.11.3 Unintended radiation 11.3.1 Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation must be reduced as far as possible.11.4 Instructions 11.4.1 The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risks inherent in installation.11.5 Ionising radiation 11.5.1 Devices intended to emit ionising radiation must be designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be varied and controlled taking account of the intended uses.11.5.2 Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way, as to achieve appropriate image and/or output quality for the intended medical purpose whilst minimising radiation exposure of the patient and user.11.5.3 Devices emitting ionising radiation, intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type and energy and where appropriate the quality of the radiation.12. Requirements for medical devices connected to or equipped with an energy source 12.1 Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to their intended use. In the event of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.12.2 Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply.12.3 Devices where the safety of the patient depends on an external power supply must include an alarm system to signal any power failure.12.4 Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health.12.5 Devices must be designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment.12.6 Protection against electrical risks Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use and in single fault condition, provided that the devices are installed correctly.12.7 Protection against mechanical and thermal risks 12.7.1 The devices must be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance, stability and moving parts.12.7.2 The devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generation by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.12.7.3 The devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.12.7.4 The terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and constructed in such a way as to minimise all possible risks.12.7.5 Accessible parts of devices (excluding any parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use.12.8 Protection against the risks posed to the patient by energy supplies or substances 12.8.1 Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow rate can be set and maintained accurately enough to guarantee the safety of the patient and the user.12.8.2 Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger. Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source.12.9 The function of the controls and indicators must be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information must be understandable to the user and, as appropriate, the patient. 13. Information supplied by the manufacturer. 13.1 Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential user. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices. Instructions for use must be included in the packaging for every device. By way of exception, no such instruction leaflet is needed for devices in Class I or Class IIa if they can be used completely safely without any such instructions. 13.2 Where appropriate this information should take the form of symbols. Any symbol or identification colour used must conform to the harmonised standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device.13.3 The label must bear the following particulars: a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or the instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14.2 or of the authorised representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate; b) the details strictly necessary for the user to identify the device and the contents of the packaging; c) where appropriate the word "STERILE"; d) where appropriate, the batch code, preceded by the word "LOT" or the serial number. e) where appropriate an indication of the date by which the device should be used, in safety, expressed as the year and month; f) where appropriate, an indication that the device is for single use; g) if the device is custom-made, the words "custom made device"; h) if the device is intended for clinical investigations, the words "exclusively for clinical investigations"; i) any special storage and/or handling conditions; j) any special operating instructions; k) any warnings and/or precautions to take; l) year of manufacture of active devices other than those covered by e). This indication may be included in the batch or serial number; m) where applicable, method of sterilisation. 13.4 If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instruction leaflet.13.5 Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components.13.6 Where appropriate, the instructions for use must contain the following particulars: a) the details referred to in 13.3 with the exception of d) and e); b) the performances referred to in section 3 and any undesirable side effects; c) if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination; d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times; e) where appropriate, information to avoid certain risks in connection with implantation of the device; f) information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment; g) the necessary instructions in the event of damage to the sterile packaging and, where appropriate, details of appropriate methods of re-sterilisation; h) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilisation of the device to be re-sterilised, and any restriction on the number of reuses. Where devices are supplied with the intention that they be sterilised before use, the instructions for cleaning and sterilisation must be such that, if correctly followed, the device will still comply with the requirements in section 1; i) details of any further treatment or handling needed before the device can be used (for example, sterilisation, final assembly, etc.); j) in the case of devices emitting radiation for medical purposes, details of the nature, type, intensity and distribution of this radiation. The instruction for use must also include details allowing the medical staff to brief the patient on any contra-indications and any precautions to be taken. These details should cover in particular: k) precautions to be taken in the event of changes in the performance of the device; l) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc. m) adequate information regarding the medicinal products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered; n) precautions to be taken against any special unusual risks related to the disposal of the device. o) medicinal substances incorporated into the device as an integral part in accordance with section 7.4; p) degree of accuracy claimed for devices with a measuring function;  m) adequate information regarding the medicinal products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered; n) precautions to be taken against any special unusual risks related to the disposal of the device. o) medicinal substances incorporated into the device as an integral part in accordance with section 7.4; p) degree of accuracy claimed for devices with a measuring function; 14 Where conformity with the essential requirements must be based on clinical data, as in section 1 (6), such data must be established in accordance with Annex X.  GUIDANCE on COMPLETING AN ESSENTIAL REQUIRWEMENTS CHECKLIST (i) The second column is used to annotate whether each ER is A applicable or Not Applicable (ii) ER #s 1 through 6 will always be applicable to all devices the rest are Product / Device specific (iii) The third Column should reference any standards that have been applied, including both Quality System (ISO 9000 & EN 46000) and any Product specific standards (IEC 601-x-y for Active devices and Sterility or Biocompatibility for non-Active devices eg: EN 5xx and IEC 10993-x + others). (iv) Any reference to Risk Analysis is taken to include prior Identification of Hazards. (v) The following documents / data should be referenced in the fourth Column. ER # 1 Design Specification, Manufacturing Specification and the Results of Hazard Identification & Risk Analysis. ER # 2 Design Specification, Design Verification and Validation and Risk Analysis. ER # 3 - Design Specification, Manufacturing Specification, Packaging Specifications, Intended Purpose and Performance Claims. ER # 4 Device Life defined and data to verify/validate that the device will Perform as Intended during its Life Time. ER # 5 - Design Specification (including verification/validation), Manufacturing Specification, Packaging Specifications must prove that the devices Performance and Safety will not be compromised during Transport and Storage. ER # 6 Risk Analysis. ER # 7 - Chemical, Physical and Biological Properties ER # 7.1 Certificates of Biocompatibility, proof of no Bio-incompatibility, no Toxicity issues, no Carcinogenic issues and Compatibility of all materials. ER # 7.2 - Design Specification (including verification/validation), Manufacturing Specification, Packaging Specifications to ensure removal of manufacturing residues. ER # 7.3 - Design Specification (including validation/validation), Manufacturing Specification. ER # 7.4 Only applicable where medicinal substances are used. ER # 7.5 - Design Specification (including verification/validation), Manufacturing Specification ER # 7.6 - Design Specification (including verification/validation), Manufacturing Specification ER # 8 Infection and Microbial Contamination ER # 8.1 - Design Specification (including verification/validation), Manufacturing Processes, Label and Instructions for Use. ER # 8.2 Only applicable where animal tissues are used. ER # 8.3 - Packaging Specifications, Manufacturing Specification regarding sterilization. ER # 8.4 - Manufacturing Specification for Sterilisation ER # 8.5 - Manufacturing Specification for Sterilisation ER # 8.6 - Packaging Specifications ER # 8.7 - Packaging Specifications ER # 9 Constructional and Environmental Properties ER # 9.1 Test Reports and Instructions for Use ER # 9.2 - Design Specification (including verification/validation) and Instructions for Use ER # 9.3 - Design Specification (including verification/validation) and Test Reports ER # 10 Devices with a Measuring Function ER 10.1/2/3 - Design Specification (including verification/validation) and Test Reports ER # 11 Protection Against Radiation ER # 11.1.1/11.2.1/11.3.1/11.4.1/11.5.x -Design Specification (including verification/validation) and Test Reports ER # 12 Requirements for Devices Connected to or equipped with an Energy Source ER # 12.1 through 12.9 Product Specific - - Design Specification (including verification/validation) and Test Reports ER # 13.3 - The Label ER # 13.3 (a) through (m) as applicable The Label ER # 13.6 Instructions for Use ER 13.6 (a) through (p) as applicable to specific products The Instructions for Use ER # 14 Will always be applicable to all products. Refer to Clinical Evaluation data, Scientific Journal critical review results or Clinical Trial data or rationale for none of these. Medical Device Directive (93/42/EEC)ESSENTIAL REQUIREMENTS COMPLIANCE CHECKLIST - Medical Device & QA Consultancy - : HYPERLINK "http://www.mdqaconsultancy.co.uk/default.htm" http://www.mdqaconsultancy.co.uk/default.htm: Tel: +44 161 980 4310: Form: ERCHECK.RTF Rev: 3 April 1995 Medical Device Directive (93/42/EEC)ESSENTIAL REQUIREMENTS COMPLIANCE CHECKLIST Completed By: Reviewed By:A or N/ARelevant Standards, In-House Procedures, Test Specs: Ref No.s and Clauses. 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