Cranage EMC and Safety (Medical Testing)

Medical Device Safety Testing Shropshire by Cranage EMC and Safety (Medical Testing)

Wallace Way, Tern Valley Business Park
Market Drayton Shropshire, UK

  • Testing and evaluation for medical equipment
  • IEC 60601 medical device safety testing
  • UKAS accredited laboratory
  • Accredited
    Experienced Staff
    UK Services
    Expert Services

    Cranage EMC and Safety (Medical Testing)

    Cranage EMC & Safety offers one of the most comprehensive testing and evaluation services for both highly sophisticated medical equipment and manual and electrical equipment, from ECG monitors, mass spectrometers, baby breathing monitors through to patient trolleys, hoists, ventilators, wheelchairs and autoclaves.

    Medical Device EMC Testing - what are the regulations?
    Within the EU, the Medical Device Regulation (EU) 2017/745 (MDR) has replaced the Medical Device Directive and the Active Implantable Medical Device Directive. The term 'medical device' covers a broad range of items, and is defined in the Medical Devices Regulation (EU) 2017/745 as 'instruments, apparatus, appliances, materials or other articles intended by the manufacturer to be used, alone or in combination, for human beings, for the purpose, prevention, monitoring, treatment or alleviation of diseases, injuries or handicaps, replacement or modification of the anatomy or physiological processes'. This definition means that simple devices, such as medical thermometers, to complex, life sustaining devices such as programmable pacemakers, are considered medical devices. The MDR (EU) 2017/745 contains 22 rules for classification, which is an increase on the previous MDD, and these are based on risk, technical design and manufacture.

    The MDR 2017/745 details the essential requirements manufacturers must meet in order to gain CE marking and sell their device within Europe, with the conformity assessment being conducted based on the risk class of the device. Within the MDR, medical devices are categorised into 4, based on their risk.

    - Class I - considered to be the lowest risk.
    - Class IIa - usually low to medium risk & not used for long periods of time, for example tracheotomy tubes.
    - Class IIb - medium to high risk and may be used for longer than 30 days, such as ventilators.
    - Class III - these are the highest risk, an example being pacemakers.

    There have been some changes to classifications within the new MDR, and therefore changes to the process of assessing conformity. It is imperative that manufacturers review these and classify their products appropriately.

    Most manufacturers of Class I devices (unless sterile or those with a measurement function) may self-declare their product confirms with the MDR. Class IIa, Class IIb and Class III must have the involvement of a Medical Notified Body to approve their Declaration of Conformity (DOC). That is where Cranage EMC and Safety come in, with our vast range of Medical Device EMC Testing experience in the field, and our test results form part of the assessment by the appropriate Notified Body. All manufacturers must produce a Technical File to show compliance and the level of detail required has changed in the new MDR. If you require Medical Device EMC Testing then Cranage are on hand to help, our highly experience team are the best in the industry, providing a second to none Medical Device EMC Testing service.

    Therapeutic and Medical Equipment Safety Testing
    Cranage is UKAS accredited for the main medical standards that are used to achieve compliance for worldwide market entry, IEC 60601-1 and IEC 60601-1-2. IEC 60601-1 outlines the general safety and essential performance requirements of medical electrical equipment, and IEC 60601-1-2 determines the requirements for electromagnetic compatibility. At Cranage, we specialise in the assessment of Class I, II and IIb medical electrical equipment with type B, BF and CF applied parts, and have extensive experience that covers a vast range of items. Our comprehensive UKAS schedule also covers the following particular requirements:

    - IEC 60601-1-11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
    - IEC 60601-2-10 Requirements for the basic safety and essential performance of nerve and muscle stimulators.
    - IEC 61010-2-101 Requirements for in vitro diagnostic (IVD) medical equipment.

    Medical Electrical Equipment Testing
    Medical electrical devices must be tested for the relevant product safety and EMC standards to ensure they are safe to use. The most common standards are IEC/EN 60601-1 and IEC/EN 60601-1-2, covering the basic safety and essential performance of medical electrical equipment. Cranage EMC and Safety is a UKAS accredited test laboratory for these standards and our team of experienced engineers can test a vast range of medical devices, with our previous tests including hospital beds, prosthetic limbs, blood pressure monitors, ultrasound devices and pulse oximetry.

    Safety Testing
    Our testing facilities for product safety include:

    - Flammability, Needle Flame and Glow wire
    - Drop testing
    - Tumble barrel
    - EMF testing and surveys
    - Mechanical and electrical testing
    - Comparative Tracking Index

    How much does CE Marking for Medical Devices cost?
    Testing is product specific, due to the range of medical devices and therefore the cost of testing varies. We are UKAS accredited for the standards IEC/EN 60601-1 and IEC/EN 60601-1-2, showing we have been assessed as technically competent for these standards. Get in touch with our team to discuss the cost of testing your medical device

    How do I get my medical device CE marked?
    CE marking is the responsibility of the manufacturer and is used to confirm the medical device meets the essential requirements of the MDD. A CE mark cannot be applied on Class IIa, Class IIb or Class III devices until a certificate has been issued by a Notified Body.

    Manufacturers must also register their device with the relevant Competent Authority, which is the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK.

    Accredited laboratory
    Using state of the art equipment to test your medical equipment Cranage EMC & Safety is here to ensure all of your testing and evaluation needs are met in full.

    IEC 60601 testing
    Our engineers also have a vast experience in testing and evaluating equipment for compensation or alleviation of injury, disease or disability.

    Cranage has core competency in all areas of MDD and IVD and constantly strives to provide absolute testing certainty, accurately and reliably, so whether your needs are for testing blood sampling equipment, gas pressure monitoring equipment or a simple weighing machine we offer a service you can trust.

    Medical Products and Equipment include but not limited to:

    - Medical Electrical Simulator for IVF
    - Blood Sampling Equipment
    - Gas Pressure Monitoring Equipment
    - Baby Breathing Monitors
    - Mass Spectrometers
    - Wheelchairs and Stair Lifts
    - Weighing Machines
    - Ventilators
    - ECG Monitors
    - Ultrasound Machines
    - PET Scanners
    - Infusion Pumps
    - Surgical Machines
    - Cardio Respiratory
    - ECG Monitors
    - Hospital Beds
    - Patient Trolleys
    - Hoists
    - Autoclaves
    - Syringe Pumps
    - X-ray Equipment
    - Dental Machines
    - MRI Machines
    - CT Scanners
    - Medical Lasers
    - Life Support Equipment

    Get in touch with our team to discuss how we can help you with your medical device testing.

    Areas Covered

    We offer medical device EMC testing, medical device safety testing and the testing of electrical medical equipment to the following locations and the rest of the UK:
    1. Bath
      County Durham
      East Sussex
      Greater London
      Greater Manchester
      Isle of Wight
      Isles of Scilly
      Milton Keynes
      North Yorkshire
      South Gloucestershire
      South Yorkshire
      West Midlands
      West Sussex
      West Yorkshire

    Opening Hours

    Monday 09:00 to 17:00
    Tuesday 09:00 to 17:00
    Wednesday 09:00 to 17:00
    Thursday 09:00 to 17:00
    Friday 09:00 to 17:00
    Saturday Closed
    Sunday Closed
    Key Personnel
    Emma Richens
    Emma Richens Marketing and Sales

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    Products and Services

    1. Appliance Testing
    2. Baby Breathing Monitor Testing
    3. Blood Sampling Equipment Testing
    4. CE Marking Medical Devices
    5. CE Testing
    6. Defibrillator Testing Solutions
    7. Electric Field Meter
    8. Electrical Equipment Test Requirements
    9. Electrical Equipment Testing
    10. Electrical Safety
    11. Electrical Safety Consultants
    12. Electrical Safety Testing
    13. Electrical Testing
    14. Electrical Testing And Inspection
    15. Electromagnetic Compatibility (EMC)
    16. Electromagnetic Compatibility Testing
    17. Electromagnetic Field Detector
    18. Electromagnetic Field Testing
    19. Electromagnetic Field Testing Services
    20. Electromagnetic Shielding
    21. Electronic Component Testing
    22. EMC
    23. EMC Certification
    24. EMC Compliance
    25. EMC Compliance Testing
    26. EMC Consultancy
    27. EMC Consultants
    28. EMC Design
    29. EMC Design Guidelines
    30. EMC Design Support
    31. EMC Design Techniques
    32. EMC Directive
    33. EMC Emissions
    34. EMC Laboratory Testing
    35. EMC On-Site Testing
    36. EMC Onsite Testing
    37. EMC Test Engineer
    38. EMC Test Equipment
    39. EMC Test House
    40. EMC Test Procedures (UKAS)
    41. EMC Test Reports
    42. EMC Testing
    43. EMC Testing Jobs
    44. EMC Testing Services
    45. EMC Testing UK
    46. EMF Assessments
    47. EMF Detector
    48. EMF Directive
    49. EMF Exposure Restrictions
    50. EMF Legislation
    51. EMF Measurement
    52. EMF Measuring Device
    53. EMF Protection
    54. EMF Quantities
    55. EMF Radiation Detector
    56. EMF Safety
    57. EMF Surveys
    58. EMF Testing
    59. EMF Testing Services
    60. EMI EMC Testing Jobs
    61. EMI Testing
    62. Environmental Environmental Testing Laboratory
    63. Environmental Testing
    64. Environmental Testing Equipment
    65. Environmental Testing Facilities
    66. Environmental Testing Laboratory
    67. Environmental Testing Service
    68. Environmental Testing Services
    69. Equipment Compliance Testing
    70. Equipment Testing
    71. Equipment Testing Services
    72. FCC Testing
    73. FCC Testing Services
    74. Gas Pressure Monitoring Equipment Testing
    75. Hospital Emergency Lighting
    76. IEC 60601 Testing
    77. Ingress Protection Testing
    78. Ingress Protection Testing Services
    79. Lighting EMF Assessments
    80. Low Voltage Directive Testing Services
    81. LVD Testing
    82. LVD Testing Services
    83. Machine Product Testing Lab
    84. Machine Products Testing Lab
    85. Machinery Testing Laboratory
    86. Mass Spectrometer Testing
    87. Material Testing
    88. Measuring EMF
    89. Medical Device Consultant
    90. Medical Device Consulting
    91. Medical Device Directive
    92. Medical Device EMC Testing
    93. Medical Device Testing
    94. Medical EMC Testing
    95. Medical Equipment Test Requirements
    96. Medical Equipment Testing
    97. Medical Equipment Testing Laboratory
    98. On-Site EMC Testing
    99. On-Site EMF Surveys
    100. Product Safety Testing
    101. Rail EMC Testing
    102. Respirator Testing
    103. RF Shielding
    104. RF Testers
    105. Safety Advice
    106. Safety And Compliance
    107. Safety Consultancy
    108. Safety Consultant
    109. Safety Consultants
    110. Safety Consulting
    111. Safety Test And Equipment
    112. Safety Test House
    113. Safety Testing
    114. Safety Testing Services
    115. UKCA Marking
    116. Ventilator Testing
    117. Weighing Machine Testing

    Associations, Memberships


    ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories

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