cGMP – Design & Development Plan (General ) – ISO 13485:2016 (5) Clause 7

Most of the designers got confused during the time of design control. The fact is, the design is better understood only being having a better structure. The manufacturing of every product includes the designing part. For instance: if a building has a better foundation, then there is very less risk of collapse. Moreover, in the case of design, the final output depends upon the design process.

The need for the design process is for medical devices, manufacturing equipment, and operation. Thus, it should be done in some better way.

The requirements management system plays an important role in making the design process in the best way. Requirement management is the process, which includes documenting, examining, tracing, prioritizing and relying on requirements and then controlling amendment and communicating to required stakeholders. It is a consecutive process throughout a project.

Moreover, agile requirements management tools refer as a Software that manages user story creation and management, track able to other needs, and test cases, tracks requirements status and amend impact analysis, ensures social collaboration to track needs related decisions and discussions, and integrates with Agile project management tools assisting backlog and requirement prioritization.

Some common mistakes are done in Design Development

The designers usually consider that design control is similar to the development process. But the fact is, the development process is a significant element of design control. The more accurate, the development process is, the more accurate will be the results.

To make the design development process flawless, you need to consider the requirements management system as it will help you to make all the designing tasks in a streamline.

Document Approval

Besides, there is some another common problem faced by the businesses is about the approval of documents. There is always a lot of efforts to be done to approve product design documents as there is a need for amendments or improvements. Moreover, the process of approval of the document is quite tedious, but with the help of Agile Requirements Management Tools, it becomes easy and seamless.

If you are seeking Agile Requirements Management Tools to make your design development process accurate and instant, then Orcanos is a well-appreciated destination as it will offer you this tool at nominal prices.

Why Is It Important To Have Design Control Medical DeviceFor Your Organization?

If you're someone who owns an organization in the field of medical devices then you need to know that Design Controls is an essential part of quality system requirements. In short, the practices of design and development also known as Design Controls as in ISO 13485 refers to the application of a set of formal quality procedures and practices to the conduct of product development especially in the field of regulated industries such as medical devices. Compared to some other domains, medical device design control and development is subject to define design control such as ISO 13485 and FDA's 21 CFR 820.30 which add to the level of formalism. 

In the field of medical device, the design controls are applied to provide and ensure concrete evidence that your innovation i.e. the designed product of yours is safe and meets the user requirements and user needs. The main objective of the design control medical device system is to follow, report and establish a methodological proven process to develop a product especially related to the medical device. Orcanos is the most reputable company that have many years of experience providing the best design control system that provides a well-defined path for your organization of any type. Having Orcanos design control system provides you with a great path from planning to design and implementation, and finally, validation and verification during which each and everything is thoroughly documented, traceability visible end to end, and risk mitigated.

As an organization owner, you might have spent years of doing best and high-quality research to create the only solution for a global need or you might have a perfect prototype available which works absolutely with no issues. However, you need to know that if you are not able to provide the required deliverables records and the perfect evidence that your device is safe, effective and suitable for its intended use then not even the best of the best medical device innovation reaches the market. If you want your product to reach on the top list of the market then perfect design control plan and documentation on your design and control activities is necessary and this is when the design and development of the actual marketable product begins.

Here are some of the benefits of Orcanos Design control system in medical devices:

• Orcanos Design control system enables your organisation to ensure and prove that your product fulfils its requirements that is regulatory standards, environmental, user etc.
• Our design control system decreases the amount of time required for corrections, rework and corrective actions.
• Enables you to ensure and prove that your product is safe effective and suitable for its intended use.
• Orcanos design control system helps you to establish a healthy basis for the development of your product and ensure the success of your business.

For more information to know about Orcanos please visit our website here: https://www.orcanos.com/compliance/

Importance of FMEA Risk Management Tool

Every business in the world has to go through risks issue. You cannot avoid risks. They are always there to knock at your door till the time you open it. Sometimes, the risk factors do not knock but bang on your office's doorstep.

However, you can always make an effort to get rid of risks through the help of an effective risk management tool or process.

A risk management system helps you identify the complete running system of the ongoing business. It helps you find loopholes and what area need to be implied after a thorough study of the whole cycle. It is all about taking steps by keeping the future in the mind. Anticipation is very vital when it comes to the business and its success.

Failure Mode and Effect Analysis (FMEA) is a process to spot the failures, effects, and risks within a process or product and then eliminate or reduce them. It is a great tool to Improve Product and Process Reliability and Reduce Risks.

Medical device industry is counted among industries that play an effective role within the society. They come up with quality medical devices which are quality tested and approved by medical researchers and regulatory specialists to ensure the safety and effectiveness of devices. To help such industries for the authorization of small and large devices, effective Risk management tools are must to comes in action.

Orcanos FMEA risk management tool is the tool that will help you to identify the possibility that errors will occur in your work and will guide you in a systematic way to control them.

The Reasons for FMEA

• Get it right the first time
• Identifies any inadequacies in the development of the product
• Tests and trials may be limited to a few products
• Regulatory reasons
• Continuous improvement
• Preventive approach
• Team building
• Required procedures

Orcanos Software was come into existence in the year 2005 by Zohar Peretz and Rami Azulay. Orcanos is the only company that provides integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specializes in the medical device industry.

The unique thing about us is our years of proven experience in a regulated hi-tech industry, working with medical device manufacturers and other high-tech companies, and assisting them in building their operational excellence.

Moreover, in order to keep your organization safe, Orcanos FEMA risk management System has scheduled alerts that will notify you on a continuous basis regarding anomalies within the process, and also impact analysis information.

From the above discussion, we can conclude that every process has the probability of failure or loss or exposure to danger. And risk management is key to success in every business. Or Risk management has become the method of choice to ensure an effective and safety oriented FEMA medical device development.

To know more about Orcanos or more please, call us at +972-3-5372561 or visit our website HERE; https://www.orcanos.com/compliance

Benefits And Importance Of ALM Requirements Traceability Matrix

The term Requirements Traceability Matrix also know as (RTM) is a high-level document to trace and map user requirements with test cases in order to ensure that each and every requirement adequate level of testing is being achieved successfully. The Traceability is defined as the process to review each and every test case that is defined for any requirement and this process also enables you to determine which requirements have got the most number of defects during the software testing process. The main aim and focus of any testing engagement or project should be 100% test coverage and requirement traceability matrix establishes a way to ensure that we place checks on the coverage aspect.

In short, requirements traceability matrix can also be referred to as a metrics that determine the most number of test cases run, passed, blocked or failed for each and every requirement and RTM also helps in creating a snapshot to identify coverage gaps. ALM requirements traceability matrix helps to link the test cases requirements and effects accurately and by having requirement traceability, the end to end testing of an application is achieved. The quality control of an application can be achieved as the software gets tested for unforeseen scenarios with all the functional and non-functional requirements being satisfied and with minimal defects. The ALM requirement traceability assures good quality control of the application as all the features are tested successfully.

Orcanos is the most reputable company that provides best requirements traceability tools that are simple and powerful for requirements traceability matrix management between any application lifecycle management ALM or QMS artefacts such as test cases, FMEA risk items, requirements, CAPA, customer complaints and more. Orcanos requirements traceability matrix aids for software application getting tested in the stipulated time period, the implementation of the project is achieved as per the customer requirements and its scope is well determined and the cost and needs of the project are well controlled. As the end to end testing and the whole of the application is tested for its requirements, the defect leakages are prevented.

Using Orcanos requirements verification traceability matrix, you can set up a traceability link type such as verification to link test cases to requirements for verification and later you can track requirements without requirements that are linked to failed test cases. Orcanos multi-level traceability matrix helps in generating a multilevel traceability report which provides you with a clear picture of your project status by showing you the relevant risks, related test cases for verification, with the linked mitigations and finally provides the results of each test in terms of pass or fail. For more information to know about Orcanos please visit our website here: https://www.orcanos.com/compliance/

Advantages of Bookkeeping with an Effective Cloud Document Management System

Technology has made it possible for organizations to rid themselves of bulging filing cabinets and rooms dedicated to archived material. Document management systems can be used to track and store electronic documents and scanned images of documents.

The entry of Cloud Based Document Management Software has transformed the way of storing a document. Users can store the document in DMS software in multiple ways, such as, by emailing, uploading, manually, and scanning. Thereafter, documents can be indexed by grouping and categorizing in various modules of this software. Indexing the documents help in easy and instant accessing of documents. Moreover, it added other benefits too such as reduced costs, off-site backups, and improved accessibility.

The DMS offers you a simple and attractive dashboard that enables seamless viewing of the workflow of your organization. By going paperless using DMS software, one can get advantages in many ways. First, by eliminating the paper-based document, one can save a big amount of money that spend on the document. Second, by choosing ISO document management software, you encourage eco-friendly workplace and it's a big step towards saving the environment.

By getting instant access to data, one can save significant office hours. Most importantly, by having data at a centralized location, data gets streamlined, which helps in direct accessing to authorized departments.

Orcanos Software was come into existence in the year 2005 by Zohar Peretz and Rami Azulay. Orcanos is the only company that provides integrated software for ALM (Design Control) and quality management (QMS), combined with regulations compliance, and specializes in the medical device industry.

The unique thing about us is our years of proven experience in a regulated hi-tech industry, working with medical device manufacturers and other high-tech companies, and assisting them in building their operational excellence.

Every business looks for ways to save costs and increase the productivity of their processes and of their employees. And with the advancements in the field of technology, there are various ways of achieving these goals. One of these ways is in using an Orcanos ISO document control software, through which business productivity can be enhanced and savings can be realized.  As Orcanos document control software system allows quick import, control automated document revision or much more in simple words, document control software is defined as a computer system that is used to store and track electronic documents or images of the paper document.

From the above discussion, we can conclude that the security of the documents is very important. Many organizations do not realize the importance of this security. The process of securing the documents is complex but a good DMS can help in securing the documents. However, understanding the document management system is an important job.

To know more about Orcanos and the Document Management system or more please, call us at +972-3-5372561 or visit our website HERE; https://www.orcanos.com/compliance