Following is breakdown of each phase in the risk management process described in ISO 14971:
4. Risk Analysis
4.3. Hazard Identification
4.4. Risk Estimation
5. Risk Evaluation
Decide whether risk should be controlled by the predefined acceptability zone (Acceptable, ALARP, Unacceptable)
6. Risk Control
6.2 Risk Control Measures
Define control type
6.4 Final Risk Evaluation – Residual Risk
6.6. New Hazard
A new hazard created? (yes/no)
7. Verification and validation
Evaluation of overall residual risk acceptability
Use QPack traceability to relate artifacts used for risk control.
The test cases (verification) should be connected to design artifacts to assure verification
So, Hazard creates the risk that can cause harm: what can go wrong, what is the likelihood for this to happen, what would be the consequences and is the risk level tolerable or not?
Example 1 : Risk analysis to mobile phone: The radiation (hazard) that caused because of crack in mobile phone body (failure cause) causes severe headaches (harm) solved by using materials according to relevant standards (risk control)
Type of optional hazards – hazard category (partial list)
Risk probability/frequency values (the probability for the harm to occur)
Risk severity values (the severity of the harm!!)
Risk control types
Risk management is supported by the following activities:
A device may contain some risks eventually, but it must be free from UNACCEPTABLE risks
IEC 60601-1 Third Ed clause 4.2 requires RM process (RMF)
Potential risk forms in QPack (partial fields) – click to enlarge:
Set of documents which contain information of the activities performed during the Risk Management process
The RMF should include:
Orcanos Welcome ATI,
ATI Advanced Medical Technologies is a developer of non-invasive diagnostic devices for the ophthalmology market. The Company has two products in its portfolio, a non-invasive pupil dilation device, called the FIM and a non-invasive tonometer to measure intraocular pressure, called the NIT.
ATI has selected Orcanos solution to support their product development lifecycle SDLC which is stands for regulation and standard that needs to meet with 510K and other requirements. QPack system will support ATI change management process and software validation as well and will be producing all relevant document for ATI customers. At the same time ATI exposure to top industry suppliers now to examine QPack support the validation procedure required by IEC 62304, IEC 62366, ISO 14971 and 61601 3rd edition for Computerized System, Information Technology and others. Having ATI under Orcanos list of customers serves Orcanos agenda in the past 5 year to be a leader solution provider for the Medical Device and aligned industries. We have been continuously working on QPack Medical™ to meet every change in authorization body requirements and standards. We are now moving forward with the Mobile Health changes and completing our product to allow small application vendors to be able to reduce the cost of compliancy by streamlining all the data under single repository – QPack Medical™.
List of presentations:
Strange as it may sound, development processes under regulatory supervision can actually be profitable for all concerned
By: Rami Azulai, joint CEO of Orcanos
In today’s decentralized and global development environments, we are also in need of a solution to provide tools for management, control and supervision throughout the entire product development project – from the stage of the requirements, planning and testing, to implementation of the software for the customer. It is not surprising, therefore, that in recent years the field of ALM (Application Life Management) has been enjoying accelerated growth among suppliers of software for implementing effective ALM solutions that create transparency and integration among the different development entities in the organization.
Many software companies around the world have already identified the advantages of implementing ALM systems, allowing different people in the organization to follow up, monitor and supervise the entire development process. In this way, at each point in time different officeholders can obtain an accurate picture of the product, not only in the development and testing sections, but also the marketing managers, who are in regular contact with the customers and update them regarding progress of the development and meeting their demands. In this way, there is full transparency throughout the entire development process, with everyone “talking” to each other with a single platform and a single source of information. This also avoids the problem of lack of communication, as the marketing manager can ensure that the developers have understood the customer’s requirements and are working according to them, and avoids development problems or situations in which the poor flow of information is liable to create delays and unnecessary work for the developers. This is particularly true in today’s age of globalization, when development companies employ software and control staff scattered at different sites around the world.
Alongside the increased awareness of the advantages provided by the ALM tool, we can expect a parallel trend of regulatory and supervisory bodies guiding the development processes and, in practice, creating standardization of the field. Today it may sound very far off, but it works in certain fields, such as biomedicine, for example, or the development of military and security systems. Today, biomedical companies are required to comply with FDA standards, and even certain telecom companies have to meet the TL 9000 standard, and the ALM systems are necessary to prove that they are in fact in compliance with the development processes and all the quality standards. It must be remembered that these companies cannot realize their business targets without the regulatory processes, and so such systems are seen as essential to their existence.
The implementation of regulatory standards will make it possible to ensure that the customer, who purchases a software product and is also required to meet high quality standards, can be certain that the development that has been ordered does in fact comply with all the most stringent regulations and standards. Furthermore, among those who are currently expressing an interest in measures of this kind are investors and venture capital companies. The reason for this is simple. When a venture capital fund or a private investor invests in a company or product, it wants to be certain that the company does indeed meet quality and effective work standards, and is not “burning” precious cash and personnel resources as a result of poor quality software products. With the ALM tool, it is possible to guarantee that the company in which they are investing is indeed capable of meeting the targets set in its business plan, and following up its performance in an ongoing and direct manner.
The development companies should also welcome such a step. Standards can only make their work easier. This does not mean that people will work harder, on the contrary – communication through the ALM tool can significantly increase efficiency, and thus streamline and improve the process at every level. There is regular, online communication, and times for responding and giving answers to the customer are considerably better, and in line with the customer’s expectations. In this way too we avoid the complexity that characterizes many software companies, which reach a situation in which the customer is dissatisfied and returns again and again to the developers, asking for a new version without bugs and problems.
In conclusion, the introduction of standards and regulatory intervention often sounds like something that will delay to market processes and cause difficulties. In the case at hand, there is no doubt that development processes supervised by means of an ALM tool can create a win-win situation and streamline development processes, no matter how complex and sensitive they are.
Medical device industry
The medical device industry is a rapid-growing industry, and so is the complexity of device technology. Medical device corporate chemical and biological ingredients and can also combine a complex mechanisms and electronic systems. Operating such systems requires complex software.
The challenge in developing medical device
Many questions are raised planning and developing such software: What should it do? How can we validate its operation? How can we predict the required effort estimation and how can we track its progress as time pass? The medical device must operate in high-level accuracy of thousandths of an inch, and measured in nanoseconds.
The goal of this module is to gather all the requirements of the device. The process of gathering requirements for a new device, or application is one of the most important phases in the development process. In order to meet company goals, these requirements must reflect customers and end users needs as well as company requirements. Market requirements come from multiple sources, such as company documentations, competitors, domain experts, marketing department and prospective users.
Gathering data from multiple resources demands a systematic process. QPack Medical MRD provides a structured system for collecting data from them, synthesizing, and then rationalizing and reducing the data. This last step is needed to remove conflicting or redundant requirements, and eliminate or annotate those requirements that are impractical based on current technology, cost constraints, or market factors.
Last stage in this process is to trace these requirements and verify they are delivered.
QPack requirements management
QPack requirements management creates a central information repository, which includes all requirements data, such as description, attributes, status information, and other information. Requirements and their associated attributes can evolve, be adapted, and be reused for subsequent development projects, lowering the overall development cost. This repository not only defines the specifics of what the system should do, it assists managers in set priorities and effort estimation, and provides up-to-date information of project progress.
QPack systematic approach allows organizing, documenting, and managing both the initial and the changing requirements of a system. A primary result of this effort is the development of one or more requirements specifications that define and document the complete behavior of the system. It allows better definition and management of the labeling claims, allows better control of the project, improve quality by combining the validation phase into the process and allows each participant in the process to understand what he should deliver. By improving team communication, and provide professional tools, Project cost is reduce significantly.