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Medical devices introduction

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Medical devices introduction

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Introduction MEDICAL DEVICES INTRODUCTION 1 Medical devices
MEDICAL DEVICES INTRODUCTION 2 Presenter’s Profile Muhammad Waqas Ali Expertise  Regulatory Affairs  Quality Management System,  Environmental management system  Occupational health and safety  Social Compliance  R&D and  Process validations Qualification: • Masters English Literature • BSc Double Math & Physics • Various Business and Auditing Courses Profession: • Working as MR in Global Tech International for the last 12 years
Table of Contents Section 1: Definition of Medical Devices Section 2: Major Groups of Instruments Section 3: Classification Intend to risk factor Section 4: Variants and Material information Section 5: Examples of Process Validations MEDICAL DEVICES INTRODUCTION 3
Definition of Medical Devices MEDICAL DEVICES INTRODUCTION 4 General Definition A medical device is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Technical Definition medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer
Technical Definition Continued MEDICAL DEVICES INTRODUCTION 5 — diagnosis, prevention, monitoring, treatment or alleviation of Disease, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
Major Groups of Instruments There are Six major groups of Instruments Surgical Instruments Dental & Orthopedic Instruments Ophthalmology Instruments Implants Diagnostic Instruments Electrosurgical Instruments 6
Anatomy Wise Categories 7 There are four main categories of instruments / devices Central Nervous System (Neurological Instruments)
Anatomy Wise Categories Central Circulatory System (Cardiovascular Instruments) 8
Types of Treatment Surface contact medical devices 9
Types of Treatment 10 Via Body Orifice (Eyes, ENT, Gynecology, Anal )
Types of Surgery Minimal Surgery and Open Surgery 11
Classification intend to risk factor 12 Product Type Duration of use Contact with active devices Risk Class Central Nervous System Transient to Long Any Very High Central Circulatory System Transient to Long Any Very High Active Implantable Devices Short to Long Any Very High Implantable Devices Short to Long Any Very High and High Active Medical Devices Transient Any High Non Active Medical Devices (Surgically Invasive) Transient If contact: If not contact: Medium Low Non Active Medical Devices (Invasive via bodily orifices) Transient If contact: If not contact: Medium Low Non Active Medical Devices Surface Contact Transient If contact: If not contact: Medium Low
13 Variants and Material information
Surgical Forceps/Scissors/Retractors etc. 1. Construction of devices shall be similar 2. Intended use shall be similar 3. Anatomy for use shall be similar 4. Risk factors shall be similar Requirements for product Variants 14
Materials Information Medical Grade Stainless Steel 300 and 400 series Polymers & Rubbers • Material Selection Requirements: 1. Material shall meet the composition or specifications of any international harmonized standards i.e. ASTM / ISO. 2. Material shall be Biocompatible ISO 10993-1 3. Material shall be compatible with applicable cleaning agents 4. Material shall meet the requirements of Sterilization ISO 11135 / ISO 17665 5. Material shall meet the requirements of claimed shelf-life 15
Process Validations Product quality in the context of process validation means that product performance is consistent from batch-to-batch and unit-to- unit. 16  Identify the internal and external critical manufacturing processes.  Adopt risk based approach (Low-medium-high)  Targeted expectation (output)  Process approach (Money, material, machine and manpower) 3 Main phases of Validation: IQ: Installation Qualification OQ: Operational Qualification PQ: Performance Qualification
17 THANK YOU

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Medical devices introduction

  • 2. MEDICAL DEVICES INTRODUCTION 2 Presenter’s Profile Muhammad Waqas Ali Expertise  Regulatory Affairs  Quality Management System,  Environmental management system  Occupational health and safety  Social Compliance  R&D and  Process validations Qualification: • Masters English Literature • BSc Double Math & Physics • Various Business and Auditing Courses Profession: • Working as MR in Global Tech International for the last 12 years
  • 3. Table of Contents Section 1: Definition of Medical Devices Section 2: Major Groups of Instruments Section 3: Classification Intend to risk factor Section 4: Variants and Material information Section 5: Examples of Process Validations MEDICAL DEVICES INTRODUCTION 3
  • 4. Definition of Medical Devices MEDICAL DEVICES INTRODUCTION 4 General Definition A medical device is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Technical Definition medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer
  • 5. Technical Definition Continued MEDICAL DEVICES INTRODUCTION 5 — diagnosis, prevention, monitoring, treatment or alleviation of Disease, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
  • 6. Major Groups of Instruments There are Six major groups of Instruments Surgical Instruments Dental & Orthopedic Instruments Ophthalmology Instruments Implants Diagnostic Instruments Electrosurgical Instruments 6
  • 7. Anatomy Wise Categories 7 There are four main categories of instruments / devices Central Nervous System (Neurological Instruments)
  • 8. Anatomy Wise Categories Central Circulatory System (Cardiovascular Instruments) 8
  • 9. Types of Treatment Surface contact medical devices 9
  • 10. Types of Treatment 10 Via Body Orifice (Eyes, ENT, Gynecology, Anal )
  • 11. Types of Surgery Minimal Surgery and Open Surgery 11
  • 12. Classification intend to risk factor 12 Product Type Duration of use Contact with active devices Risk Class Central Nervous System Transient to Long Any Very High Central Circulatory System Transient to Long Any Very High Active Implantable Devices Short to Long Any Very High Implantable Devices Short to Long Any Very High and High Active Medical Devices Transient Any High Non Active Medical Devices (Surgically Invasive) Transient If contact: If not contact: Medium Low Non Active Medical Devices (Invasive via bodily orifices) Transient If contact: If not contact: Medium Low Non Active Medical Devices Surface Contact Transient If contact: If not contact: Medium Low
  • 14. Surgical Forceps/Scissors/Retractors etc. 1. Construction of devices shall be similar 2. Intended use shall be similar 3. Anatomy for use shall be similar 4. Risk factors shall be similar Requirements for product Variants 14
  • 15. Materials Information Medical Grade Stainless Steel 300 and 400 series Polymers & Rubbers • Material Selection Requirements: 1. Material shall meet the composition or specifications of any international harmonized standards i.e. ASTM / ISO. 2. Material shall be Biocompatible ISO 10993-1 3. Material shall be compatible with applicable cleaning agents 4. Material shall meet the requirements of Sterilization ISO 11135 / ISO 17665 5. Material shall meet the requirements of claimed shelf-life 15
  • 16. Process Validations Product quality in the context of process validation means that product performance is consistent from batch-to-batch and unit-to- unit. 16  Identify the internal and external critical manufacturing processes.  Adopt risk based approach (Low-medium-high)  Targeted expectation (output)  Process approach (Money, material, machine and manpower) 3 Main phases of Validation: IQ: Installation Qualification OQ: Operational Qualification PQ: Performance Qualification