Medical devices quality system requirements

It is very important to ensure that having a signed paper-based record (e.g., a report) associated with one or more electronic records, the electronic file(s) associated with these records must not be deleted. The Part 11 regulation is very specific regarding this issue. Electronic files in hybrid systems must be maintained electronically. The interpretation of this requirement in the medical devices CGMP regulations (21 CFR 820) is different. Part 820 requires that the results of acceptance activities are recorded, but are not necessarily raw data, and these results must have audit trails. This interpretation is contained in the medical device quality system preamble (pp. 52631 and 52646). 

International Organization for Standardization (ISO), (2003), Medical devices—Quality management systems—Requirements for regulatory purpose, ISO 13485 2003, ISO, Geneva. 

ISO 13485 Medical devices. Quality management systems. Requirements for regulatory purposes... 

The Quality System Regulation is introduced for medical devices, requiring developers of high-risk devices to apply design controls. 

The example of the textile chain demonstrates (i) how much the techni-cal/aesthetic quality of products and chemicals-related product security are interdependent and (ii) what requirements exist for a quality management system beyond the supply chain level. Only the major brands can take this initiative on a global scale. For cosmetic, medical devices and food products, as well as technical products with high safety requirements (such as aircraft), management systems beyond supply chain level have now become a matter of survival. The same holds true for products that are subject to special waste and design regulations in Europe (such as automotive vehicles and electronic equipment). 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

Table 2 Requirements of Quality System for Medical Devices...

CFR21 Section 820.5 Quality System Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets requirements of this section. 

Validation in quality systems includes establishment of procedures on how to qualify the equipment and machinery, how to verify the design of products, how to verify the process designed, how to verify the achievement of production procedures, how to validate the process developed, and how to validate the methods for measurement and assay. Validation also requires verification of specifications or acceptance criteria of in-process parameters relating to both raw materials and intermediate (in-process product) and finished products, and verification of acceptance criteria for in-process parameters relating to operating conditions of machinery and equipment. Further, when the medical device is assembled at the user s site, validation includes establishing procedures of how to verify assembly. 

ISO 13485. Quality Systems-Medical Devices Particular Requirement for the Application of ISO 9001. Switzerland (1997). 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

The guarantee of conformity to the essential requirements of the MDD is provided by the interaction between the manufacturer and a third party, the notified body. The notified bodies are organizations that are recognized by the member states to conduct device evaluations and inspections of the quality systems of the various manufacturers. The manufacturers are held responsible for the quality, safety, and effectiveness of their medical devices. This is enforced through the manufacturer s written declaration of conformity and commitment to keep all technical information available for inspection by the notified bodies and national authorities. 

The primary FDA regulations apphcable to medical device product software are 21 CFR 820.70(i), 21 CFR 820.30 and all of the CPGs discussed in this chapter. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer s quality system. According to 21 CFR 820.70(i) the automated system must be qualified for its intended use to ensure system... 

The submission of an application conveys an acceptance of certain responsibilities, including the accuracy and the quality of the data as well as the required subsequent reporting and technical commitments for the product and its intended use. To assure the accuracy and quality of the data and information provided in applications, the Act gives the FDA broad authority to inspect pharmaceutical and medical device establishments, including manufacturers and other research testing facilities from which data are derived. Applicants therefore must have documented systems in place for all processes from which data are derived and included... 

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