Medical Standards

ISO 13485 (Quality Management System for Medical Devices)

ISO 13485is a quality system standard designed specifically for medical device companies. The ISO13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices.

The quality management system requirements specified in the ISO 13485 standard complementstechnical requirements for products. The primary purpose of the ISO 13485 standard is to facilitate harmonized medical device regulatory requirements for quality systems.

GMP (Good Manufacturing Practice)

GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act.

These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.

GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous.

GMP regulations address issues including recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.

 

CE Marking

Devices that conform to these requirements are entitled to show the CE marking which allows the product to be freely available in the market within EU. All Medical Devices being marketed in the EU must bear CE marking.

 

FDA (Federal Drug Authority)

FDA is the Federal Agency responsible for ensuring that foods are safe, wholesome and sanitary, human and veterinary drugs, biological products, and medical devices are safe and effective, cosmetics are safe, and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.

 

Devices that conform to these requirements are entitled to show the CE marking which allows the product to be freely available in the market within EU. All Medical Devices being marketed in the EU must bear CE marking.

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