Overview of Medical Devices and Regulatory Compliance

Introduction to medical devices, including definitions, classifications, and major groups of instruments. Learn about the technical and general definitions, the benefits of medical devices for patients, and the expertise required in regulatory affairs and quality management systems.

• Medical Devices
• Regulatory Compliance
• Healthcare
• Instruments
• Quality Management

venus Follow

Uploaded on Jul 27, 2024 | 0 Views

Download Presentation

Please find below an Image/Link to download the presentation.

The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.

Presentation Transcript

1. Medical devices Introduction MEDICAL DEVICES INTRODUCTION 1

2. Presenters 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 MEDICAL DEVICES INTRODUCTION 2

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 C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png 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 to be used for human beings for the purpose of: MEDICAL DEVICES INTRODUCTION 4

5. Technical Definition Continued C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png 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. MEDICAL DEVICES INTRODUCTION 5

6. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png 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. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Anatomy Wise Categories There are four main categories of instruments / devices Central Nervous System (Neurological Instruments) 7

8. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Anatomy Wise Categories Central Circulatory System (Cardiovascular Instruments) 8

9. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Types of Treatment Surface contact medical devices 9

10. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Types of Treatment Via Body Orifice (Eyes, ENT, Gynecology, Anal ) 10

11. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Types of Surgery Minimal Surgery and Open Surgery 11

12. Classification intend to risk factor C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png 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 12

13. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Variants and Material information 13

14. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Requirements for product Variants 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 5. Acceptability Criteria 14

15. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png 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. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png Process Validations Product quality in the context of process validation means that product performance is consistent from batch-to-batch and unit-to- unit. 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 16

17. C:\Users\vcicero\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.IE5\UDH751QD\MC900442122[1].png THANK YOU 17