Management System Certifications

Zenith provides audit and certification services as per ISO 13485 Medical Devices – Quality Management Systems and ISO 9001 Quality Management Systems to organizations who are covered in the below mentioned Technical Areas of Medical Devices and In-Vitro Diagnostic.

Medical Devices Technical Area (IAF MD9) for ISO 13485 (Codes & Description of Technical Area)

A.1.1 – Non-active medical devices

General non-active, non-implantable medical devices

• Non-active devices for anaesthesia, emergency and intensive care
• Non-active devices for injection, infusion, transfusion and dialysis
• Non-active orthopaedic and rehabilitation devices
• Non-active medical devices with measuring function
• Non-active ophthalmologic devices
• Non-active instruments
• Contraceptive medical devices
• Non-active medical devices for disinfecting, cleaning, rinsing
• Non-active devices for in vitro fertilization (IVF) and assisted reproductive technologies (ART)
• Non-active medical devices for ingestion

Non-active implants

• Non-active cardiovascular implants
• Non-active orthopaedic implants
• Non-active functional implants
• Non-active soft tissue implants

Devices for wound care

• Bandages and wound dressings
• Suture material and clamps
• Other medical devices for wound care

Non-active dental devices and accessories

• Non-active dental devices/equipment and instruments
• Dental materials
• Dental implants

Non-active medical devices other than specified above

A.1.2 – Active medical device (Non-implantable)

General active medical devices (non-implantable)

• Devices for extra-corporal circulation, infusion and haemopheresis
• Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
• Devices for stimulation or inhibition
• Active surgical devices
• Active ophthalmologic devices
• Active dental devices
• Active devices for disinfection and sterilization
• Active rehabilitation devices and active prostheses
• Active devices for patient positioning and transport
• Active devices for in vitro fertilization (IVF) and assisted reproductive technologies (ART)
• Software
• Medical gas supply systems and parts thereof

Devices for imaging

• Devices utilizing ionizing radiation
• Devices utilizing non-ionizing radiation

Devices for monitoring

• Monitoring devices of non-vital physiological parameters
• Monitoring devices of vital physiological parameters

Devices for radiation therapy and thermo therapy

• Devices utilizing ionizing radiation
• Devices utilizing non-ionizing radiation
• Devices for hyperthermia / hypothermia
• Devices for (extracorporal) shock-wave therapy (lithotripsy)

Active (non-implantable) medical devices other than specified above

A.1.4 – In Vitro Diagnostic medical device (IVD)

Reagents and reagent products, calibrators and control materials for:

• Clinical Chemistry
• Immunochemistry (Immunology)
• Haematology/Haemostasis/ Immunohematology
• Microbiology
• Infectious Immunology
• Histology/Cytology
• Genetic Testing

In Vitro Diagnostic Instruments and software

IVD medical devices other than specified above

A.1.5 – Sterilization methods for medical devices

• Ethylene oxide gas sterilization (EOG)
• Moist heat
• Aseptic Techniques
• Radiation sterilization (e.g. gamma, x-ray, electron beam)
• Sterilization method other than specified above

A.1.6 – Devices Incorporating/Utilizing Specific Substances/Technologies

• Medical devices incorporating medicinal substances
• Medical Devices Utilizing Tissues of Animal origin
• Medical devices incorporating derivate of human blood
• Medical devices utilizing micromechanics
• Medical devices utilizing nanomaterials
• Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed
• Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above.

A.1.7 – Parts and Services 

• Raw materials
• Components
• Subassemblies
• Calibration services
• Distribution services
• Maintenance services
• Transportation services
• Other services

Zenith provides these audit and certification services under accreditation regime of Internationally recognised Accreditation Bodies.