Course Details

  • Assessment by coursework
  • Peer assessed
  • 1 document
  • Technical file
  • Hand-in date 12th December

    Technical File: Get details from Kirstie
  • Spec
  • Description
  • Annex 1 checklist
  • Verification
  • Validation
  • Clinicial evidence and evaluation
  • —


Overview

Principles of getting a device to market: * Process is planned * Process is organised * Process is reviewed * Process is documented

Met by: * a quality system * thorough product testing

Regulatory requirements: * Europe - Medical Devices Regulation (CE Mark) * US - FDA * Japan - Ministry of Health and Welfare

Classification of Devices in Europe: * Class 1 -> * Class 2 ->


Compliance for Medical Devices

15 Steps to Compliance for Medical Devices: * Determine it is a medical device * Determine the scope of the device * Determine the device certification * Select a conformity assessment procedure * Identify applicable “essential requirements” * Product safety requirements - risk assessment * Implement as ISO 13485 QMS * Design Verification and Validation including - Performance evaluation - Usability Engineering - Clinical Evaluation and Clinical Investigation

  • Assemble “Technical documentation”
  • Apply the conformity assessment procedure (notified body assessment needed?)
  • Affix “CE MARK”, Declaration of conformity, UDI and register with competent authority
  • Appoint an authorised representative
  • Review and update PMS and PMCF
  • Plan for Unannounced Audits

CE MARK * Understand and comply with the regulations * Develop your device under a QMS and gain ISO 13485 * Develop your device in planned stages

ISO Standards: * ISO means international * Each country has slightly different ISO standards * “Mandatory” and “Where Applicable” standards * BSI Shop is a place to go to buy ISO standards

MDDEVS’s: * Guidance documents provided for companies where no ISO standards exists or as additional information

Medical Device vs IVD: * Medical devices touch/analyse the human directly * IVD analyses samples of human cells etc, something that comes out of the body * The definitions in the CE Regulations very much determine what is an IVD or MD - intended purpose and context of use very important * CE Regulations - MDR - IVDR

What is a quality management system? * QMS is a set of written procedures for every process



Positional Terminology Terms

Common words to describe the position of anatomical structures:

  • Anterior: - To the front.
  • Posterior: - To the back.
  • Superior: - Above.
  • Inferior: - Below.
  • Lateral: - Away from the midline.
  • Medial: - Towards the middle.
  • Proximal: - Closer to the middle of the body.
  • Distal: - Further away from the middle of the body.
  • Superficial: - Closer to the surface of the body.
  • Deep: - Further away from the surface of the body.



Anatomical Position

  • Body standing erect
  • Body facing forwards
  • Legs together
  • Feet parallel with toes pointing forwards
  • Arms hanging loosely
  • Palms of hands facing forwards (thumb lateral)



Anatomical Terminalogy relating to Bones

  • Condyle: - a round protuberance that occurs at the end of some bones.
  • Epicondyle: - the protuberance above a condyle at the end of an articulating bone.
  • Fossa: - a depression or hollow.
  • Foramen: - a hole.
  • Process: - a thin prominence or protuberance.
  • Ramus: - a thin process projecting from a bone.
  • Spine: - a sharp process of a bone.
  • Sulcus: - groove.
  • Trabecula: - the thin bars of bony tissue in spongy bone.
  • Lamella: - thin bands of calcified bone matrix.
  • Trochlear: - an anatomical part having the structure or function of a pulley.
  • Tuberosity: - a large rounded protuberance on a bone / expanded / pulled out.
  • Facet: - plate like surface.



Planes of Motion

  • Sagittal Plane: - can be seen when standing side on to someone.
  • Coronal Plane: - can be seen when you stand in front of / behind someone.
  • Transverse Plane: - can be seen when you stand above or below someone.
Planes of Movement



Movements

Sagittal Plane

Flexion: - involves ‘the bending of two adjacent body segments so that their two anterior/posterior surfaces are brought together’ (Palastanga & Soames, 2012, p3).

  • Hip flexion
  • Knee flexion
  • Ankle flexion
  • Plantarflexion.
Sagittal Plane Flexion

Extension: - involves ‘the moving apart of two opposing surfaces’ or ‘movement beyond the neutral position’ (Palastanga & Soames, 2012, p3).

  • Hip extension
  • Knee extension
  • Ankle extension
  • Dorsiflexion.
Sagittal Plane Extension



Coronal Plane

Abduction: - ‘The movement of a body segment such that it moves away from the midline of the body’ (Palastanga & Soames, 2012, p3).

  • Hip abduction
  • Knee abduction
  • Ankle abduction.
Coronal Plane Abduction

Adduction: - ‘The movement of a body segment in a coronal plane such that it moves towards the midline of the body’ (Palastanga & Soames, 2012, p3).

  • Hip adduction
  • Knee adduction
  • Ankle adduction
Coronal Plane Adduction



Transverse Plane

Medial Rotation: - ‘Rotation of a limb segment about its longitudinal axis so that the anterior surface comes to face the midline of the body’ (Palastanga & Soames, 2012, p3).

  • Medial (internal) hip rotation
  • Medial (internal) knee rotation.
Transverse Plane Medial

Lateral rotation: - ‘Rotation of a limb segment about its longitudinal axis so that the anterior surface faces away from the midline’ (Palastanga & Soames, 2012, p3).

  • Lateral (external) hip rotation
  • Lateral (external) knee rotation.
Transverse Plane Lateral

Other

Lecturer Warren Macdonald - w.macdonald@imperial.ac.uk