ISO 13485 certification outlines the framework for businesses to give high-quality medical equipment to the satisfaction of customers, clients, and stakeholders. Businesses are attached to one or more phases of the life cycle of a Medical Device like as design, implementation, storage, distribution, installation, and technical support.
What Do You Mean by Non-Active Medical Devices?
Medical devices that are not active are included in the Main Technical Areas under the ISO 13485:2016 Certification. Additionally, the Main Technical Areas fall into four groups, which are as follows:
All-purpose Non-Implantable, Non-Active Medical Equipment: Medical devices that are not active do not require an external energy source to function. These devices are essential in medical environments, and they must undergo extensive testing to guarantee both intended operation and user safety.
It consists of:
- Non-active tools for critical care, anaesthesia, and emergencies
- Injectable, transfusion, infusion, and dialysis non-active devices
- Non-invasive medical devices featuring a measurement feature
- Inactive ophthalmic instruments
- Non-active medical equipment for washing, rinsing, and disinfecting
Non-Active Implants: Inactive implants enclose various types, such as non-active cardiovascular, orthopaedic, functional, and soft tissue implants are among the many varieties of inactive implants. Additionally, these implants are not intended for long-term implantation into the human body.
It comprises:
- Cardiac implants that are not active
- Orthopaedic implants that aren't in use
- Functional implants that are not in use
- Soft tissue implants that are not active.
Equipment for Treating Wounds: Medical equipment for wound care aids in wound dressing. Supplies including cotton wool, bandages, gauze dressings, sutures for closing wounds on the skin that heal faster than 30 days, and surgical gloves are included in this category. Antimicrobial agents and animal tissues are not used in the production of these gadgets.
It comprises:
- Bandages and wound care products
- Suture materials and clamps.
- Additional medical equipment for managing wounds
Non-Active Dental Devices and Accessories: These non-active dental devices and accessories include various dental instruments, which ranging from X-ray cones to face bows. Additionally, it includes dental materials and implants.
- Non-active dental instruments and equipment
- Dental materials
- Dental implants
The ISO 13485 certification specifies additional requirements designed specifically for the medical device and healthcare industries to address patient safety issues and increased hazards. To efficiently govern processes and services, this certification is applying to enterprises and provides comprehensive recommendations for setting up, overseeing, and maintaining quality management systems.
To Know the Globalmanagergroup.com
Globalmanagegroup.com has 25 years of experience in ISO certification systems. They have 2700 clients in 36 countries. They offer an ISO 13485 document packages for Medical Devices. The Documents kit includes ISO 13485 Manual, ISO 13485 Procedures, Exhibits, Formats, ISO 13485 Audit Checklist, SOPs, Filled forms, and so on. The ISO 13485 Audit checklist includes more than 900 Audit questions. All these documents are in editable formats and written in simple English language. The ISO 13485 documents contain more than 100 editable MS Word files. In addition to saving time and money, it helps consultants and trains staff to perform better in the pharmaceutical industry.
