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Medical Devices Standards

Medical Devices Standards

Medical devices made to a Standard

Organisations within the medical devices industry have a responsibility to meet safety and quality requirements, to ensure safe use for the end consumer. 

The industry is demanding, where innovation is essential to keep moving forward with medical services, procedures and care. While striving to create better, safer and more reliable products and services, all current and future projects must work towards meeting the regulatory requirements. 

Standards help guide organisations through all business functions, including product development, quality assurance, management strategies and even cost efficiencies. 

It's important to remember that compliance within the medical devices industry means much more than just ticking boxes. It can mean crucial differences of the performance of a product or service, directly affecting the end consumer. Being able to rely on safe, standardised, and predictable devices that meet the required Standards can shorten development and production times, allowing for swift solutions in a variety of circumstances.

Medical devices Quality management systems Requirements for regulatory purposes
Published: 25-Feb-2016
Medical devices Application of risk management to medical devices
Published: 10-Dec-2019
Set of Standards recognized essential principles of safety and performance of medical devices
Sterilization of health care products
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Published: 17-Aug-2018
Protective gloves against dangerous chemicals and micro-organisms Part 5: Terminology and performance requirements for micro-organisms risks
Published: 12-Oct-2016
Protective clothing — General requirements
Published: 04-Jul-2013
Medical devices Guidance on the application of ISO 14971
Published: 16-Jun-2020
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices Part 1
Published: 06-Jul-2021
Medical devices — Information to be supplied by the manufacturer
Published: 13-Apr-2021
Reprocessing of reusable medical devices and other devices in health and non-health related facilities
Published: 15-Dec-2023
Health records Digitized health records
Published: 24-Jul-2019
Technical systems and aids for people with disability
Published: 16-Oct-2015
Vendor Credentialing for Healthcare Facilities
Published: 12-Apr-2018
Management programs for medical equipment
Published: 31-Oct-2012
Breath alcohol testing devices
Published: 28-Jun-2019
Health records Paper health records
Published: 24-Jul-2019
Management of clinical and related wastes
Published: 21-Dec-2018
Standard Specification for Barrier Face Coverings
Published: 15-Mar-2024
American National Standard for Occupational an Educational Personal Eye and Face Protection Devices
Published: 13-Apr-2020
Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
Published: 06-May-2009
Fundamental aspects of safety standards for medical electrical equipment
Medical electrical equipment - ALL PARTS
Published: 09-Jan-2024
Medical devices - Part 1: Application of usability engineering to medical devices
Published: 17-Jun-2020
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