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What kind of standard system should be followed for PCB Assembly of medical devices?

In the field of medical devices, PCBA is a vital part, and its quality is directly related to the safety and effectiveness of medical devices.

However, compared with general electronic products, PCB assembly of medical devices needs to meet more stringent standards and requirements. So, what kind of standard system should PCB assembly of medical devices follow?

ISO 13485 Quality Management System

ISO 13485 is a quality management system standard developed by the International Organization for Standardization for the medical device industry. The standard emphasizes quality management at all stages of the product life cycle, including design and development, manufacturing, assembly and service.

For PCB assembly, ISO 13485 requires manufacturers to establish a complete quality management system to ensure that every link from raw material procurement, manufacturing and assembly to product inspection and delivery meets quality requirements.

IPC-A-610 Electronics Assembly Acceptance Standard

IPC-A-610 is an electronic assembly acceptance standard developed by the Association Connecting Electronics Industries. This standard describes in detail the quality and reliability acceptance criteria for electronic assemblies, including soldering quality, component location, wire connections, etc.

For medical device PCB assembly, IPC-A-610 is an important basis for judging the welding quality and whether the entire electronic assembly meets the requirements.

IEC 60601-1 Basic safety standard for medical electrical equipment

IEC 60601-1 is the basic safety standard for medical electrical equipment developed by the International Electrotechnical Commission. This standard specifies the basic safety requirements for medical electrical equipment, including electrical safety, mechanical safety, and electromagnetic compatibility.

For medical device PCB manufacturing, IEC 60601-1 is an important basis for ensuring that the processed electronic assemblies meet the basic safety requirements for medical electrical equipment.

FDA QSR 820 Quality Management System Requirements

FDA QSR 820 is a quality management system requirement set by the U.S. Food and Drug Administration for medical device manufacturers. This requirement emphasizes quality management at all stages of the product life cycle, including design control, process control, corrective and preventive measures, etc.

For PCB assembly of medical devices exported to the United States, FDA QSR 820 is a standard system that must be followed.

GMP Good Manufacturing Practice

GMP is the abbreviation of Good Manufacturing Practice, which is an autonomous management system that focuses on product quality and health safety during the manufacturing process. In the field of medical devices, GMP requires manufacturers to have complete production facilities, strict operating procedures and an effective quality management system to ensure product quality and safety.

For medical device circuit board manufacturing, GMP is an important basis for ensuring that the processed electronic assemblies meet the requirements of good manufacturing practices.

UL certification and CE certification

UL certification is the abbreviation of Underwriter Laboratories Inc., an independent, non-profit professional organization that conducts tests for public safety. CE certification is the EU's safety certification mark and is a basic requirement for products to enter the EU market.

For medical device circuit board assembly, UL certification and CE certification are the passports for products to enter the international market, and are also important guarantees for ensuring product quality and safety.

Medical device PCB manufacturing needs to follow a series of strict standard systems, including ISO 13485 quality management system, IPC-A-610 electronic assembly acceptance standard, IEC 60601-1 medical electrical equipment basic safety standard, FDA QSR 820 quality management system requirements, GMP good manufacturing practice, UL certification and CE certification.

These standards and requirements are important guarantees for ensuring product quality and safety, and are also key factors in improving product competitiveness and market share. If you have any PCB manufacturing needs for medical devices, please feel free to contact us at Bittele Electronics. We will wholeheartedly provide you with professional support and solutions.

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