Smartware

Smartware is defined as the software and electronics that power medical devices, and the priority given to them throughout the development process in order to achieve efficiencies and avoid potential costly pitfalls. The Smartware Approach to Device Development Medical Device Smartware is focused on the entire development pathway of your medical device and making software a priority, no matter where you are in that pathway.
Smartware strategies take into consideration the full spectrum of needs which include but are not limited too development, verification and validation, quality systems, DHF remediation,expert testimony, and GMP/QSR/ISO reviews. This approach has a broad utility across a wide range of medical specialties.
Definitions
Verification and Validation

Verification is a Quality control process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process.
Validation is a Quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.
It is sometimes said that validation can be expressed by the query "Are you building the right thing?" and verification by "Are you building it right?" "Building the right thing" refers back to the user's needs, while "building it right" checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.
Quality System

Quality System requirements for medical have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983, and were instituted as requirements in a final rule published on October 7, 1996. The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at 21 CFR 820.
According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.
The FDA has identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements. These elements include:
Quality System
* personnel training and qualification
* controlling the product design
* controlling documentation
* controlling purchasing
* product identification and traceability at all stages of production
* controlling and defining production and process
* defining and controlling inspection, measuring and test equipment
* validating processes
* product acceptance
* controlling nonconforming product
* instituting corrective and preventive action when errors occur
* labeling and packaging controls
* handling, storage, distribution and installation
* records
* servicing
* statistical techniques
all overseen by Management Responsibility and Quality Audits.
Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.
Drug manufactures are regulated under a different section of the Code of Federal Regulations: 21 CFR 211. However, the FDA has instituted new policies requiring QS for pharmaceuticals.
Design History File Remediation
Design History File is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control records of the device.
Medical Software
In computers, medical software is a significant branch of software engineering. Many medical devices that monitor or control patients are predominantly controlled by software. Medical devices are frequently regulated and must comply with local and regional laws. In the European Union, these includes the Medical Devices Directive. In the United States, the Food and Drug Administration has increased its involvement in reviewing the development of medical device software starting in the mid-1980s, where coding errors in a radiation therapy device (Therac-25) resulted in the overdose of patients. FDA is now focused on regulatory oversight on medical device software development process and system-level testing. In the recent years,1995-2005 IEC 62304 has become the benchmark standard for the development of medical software.
Types of medical software
;Monitors: heart rate, blood pressure, breathing rate, use software to interpret the sensor information and display it in a meaningful way on a monitor.
;Medication pumps: These devices are programmed to pump a certain amount of plasma, blood, saline solution, or other medication into a patient at a certain rate. The software provides the ability to control many aspects of treatment procedures.
;Analysis: Many devices, such as X-ray computed tomography scanners (CT or CAT scans), measure raw data that is essentially meaningless to people. Software reinterprets this data to create images that doctors can read and understand.
;Expert Systems: A variety of expert systems help clinicians and practitioners in decision making for diagnostic and therapeutic purposes.
;Therapy delivery: The software in implantable pacemakers and defibrillators provides fault-tolerant, real-time, mission-critical monitoring of cardiac rhythms and associated therapy delivery.
;Medical and healthcare educational software: Software used as an educational or study tool for health care professionals.
;Medical informatics: Software for the business and informational aspect of medicine; these include electronic medical record (EMR), electronic health record (EHR), practice management, and the analytics software that works with these systems.
Classification of Medical Software
Medical Software could be classified simply into the following groups, depending on its use. This is called utilitarian classification by Harry Gouvas 1988, but sometimes there are overlaps:
* (I) Educational Medical Software (Educational Medical Software, EMS): (Ia): Built-in Device and (Ib): Not built-in appliances.
* (II) Medical Diagnostic Software (Diagnostic Medical Software, DMS): (IIa): Built-in Device and (IIb): Not built-in appliances.
* (III) Therapeutic Medical Software (Therapeutic Medical Software, TMS): (IIIa): Built-in Device and (IIIb): Not built-in appliances.
* (IV) Medical Design Software (Design Medical Software, DEMS): (IVa): Built-in Device and (IVb): Not built-in appliances.
Examples: A program that monitors and shows the heart rate, blood pressure and blood oxygen, a monitor, is the built-in diagnostic software, Category IIa. A free medical program called eg "Infection" that accepts symptoms and makes diagnosis of infection, belongs to the Ib. A program for example the "Scan" which is loaded on a CT scanner and processed by the X-ray signal, to reproduce the picture, belongs to a class IIa. A program eg the "Press" built in "chip" a digital sphygmomanometer, belongs to a class IIa. A program example in "Coral" of a company that manufactures total hip and Freedoms (PC designer) belongs to the class IVb, while the program eg the "Coral-CAD" embedded in machines for cutting and construction of intentional belongs to IVa. The software that controls the machine Laser Surgeons in patients with myopia automatically belongs to the class IIIa. As noted above there may be overlaps. This is particularly true in the category (I). A medical education program, might well have as its object to diagnose or treat disease.

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