What Is the Medical Device ISO13485 and How to Certify?

  Author:MeCan Medical–ultrasound machine manufacturers

What is ISO13485 certification? It is aimed at the quality management system standards for the medical device industry. It has guiding significance to the establishment of the quality system of the medical device industry. Medical equipment production enterprises and business enterprises can all be certified according to the actual business situation. The basic requirements of the quality management of equipment operation are suitable for all operators engaged in medical device business activities. Medical device business enterprises shall take effective quality control measures in the section of medical device procurement, acceptance, storage, sales, transportation, and after -sales service to ensure the quality and safety of the products during the operation.

ISO13485 is based on the characteristics of medical device production on the basis of ISO9001, and proposes special requirements for pollution, environmental control, risk analysis, and sterilization to ensure the safety and effectiveness of medical devices. ISO13485 is an international standard. From management responsibilities, resource management, product implementation and measurement, analysis and improvement, professional guidance is given to the complete quality management system, but the standard only puts forward some key elements to establish a program for forming files related requirements.

After simply understanding what the medical device is ISO13485 is, many will ask if all companies that operate medical devices need this certification? What is the difference between it?

Medical Device GSP is the basic requirement for operating enterprises, and it is the bottom line of compliant operations in operating enterprises; ISO13485 is not a compulsory standard for medical device business enterprises, so enterprises can conduct comprehensive considerations according to their actual situation. If the medical device business enterprise fails to plan the ISO13485 certification when the GSP system is newly built, it can still learn from the ISO13485 standard in a timely manner.

What Is the Medical Device ISO13485 and How to Certify? 1

recommended articles
Case Info Center AI Blog
What Is the Extraction Step of the Magnetic Pearl Nucleic Acid Extract Instrument and What Are the C
  Author:MeCan Medical–ultrasound machine manufacturersThe nucleic acid extract instrument is a supporting nucleic acid extract reagent from the motion to complete t...
What Is the Working Principle of Magnetic Pearl Nucleic Acid Extract Instrument? What Are the Charac
  Author:MeCan Medical–ultrasound machine manufacturersNucleic acid extraction instrument is an instrument that uses a supporting nucleic acid extract reagent from t...
What Is the Principle of Magnetic Pearl Nucleic Acid Extraction Instrument? What Are the Advantages?
  Author:MeCan Medical–ultrasound machine manufacturersIn recent years, the nucleic acid extract in the principle of magnetic beads has become the mainstream nucleic...
How to Use Sleep Ventilator? Tell You These Five Operation Steps
  Author:MeCan Medical–ultrasound machine manufacturersHousehold ventilator is mainly home medical devices for crowds such as snoring and breathing. This ventilator ...
What Are the Application Scenarios of an Electrolyte Analyzer and What Should I Pay Attention to in
  Author:MeCan Medical–ultrasound machine manufacturersThe electrolyte analyzer is indispensable in clinical examinations, and it mainly detects human blood in the c...
Shuiguang Needle Is Intended to Be Supervised According to the Three Types of Medical Devices, and t
  Author:MeCan Medical–ultrasound machine manufacturersAfter the impact of Internet culture and the education of the medical beauty industry, people's acceptance of ...
When Detecting Blood Sugar, What Is the Difference Between the Home Blood Glucose Meter and the Hosp
  Author:MeCan Medical–ultrasound machine manufacturersBlood glucose meter detection of blood glucose is a simple, convenient, and fast detection method, which is be...
What Is a Nucleic Acid Extract Instrument? Introduction
  Author:MeCan Medical–ultrasound machine manufacturers核酸是生物的遗传物质也是分ड...
Why Do Patients with Slow Pulmonary Blockers Need Non -invasive Ventilator? What Is the Application
  Author:MeCan Medical–ultrasound machine manufacturersNow the continuous increase in patients with slow pulmonary blocking, how should this situation be relieved? I...
What Do I Need to Check Before Startup? Daily Maintenance Method
  Author:MeCan Medical–ultrasound machine manufacturersIn the daily physical examination and inspection of color Doppler ultrasound, we often come into contact with ...
no data
One-stop medical & laboratory equipment supplier,focus on medical equipments over 10 years
Contact us

If you have a question, please contact at contact info@mecanmedical.com

+86 020 8483 5259
no data
Copyright © 2021 Guangzhou MeCan Medical Limited  | Sitemap
chat online
Leave your inquiry, we will provide you with quality products and services!
contact customer service