ISO 14971:2019 Compliance: Trace to design control mitigations

The ISO 14971 is an ISO standard for those companies involved in the manufacturing of medical devices. It intended for improving company processes and standardizes manufacturing procedures so that the risks associate with electronic medical devices can be mitigated. It is a set of points for risk management and adopting best practices while developing a device used in the medical industry.

There are three different versions of the ISO 14971

ISO 14971:2007- This was the first standard that was made by the world governing body for medical devices. It was replaced by the ISO 14971:2019.

ISO 14971:2019- It replaced the ISO 14971:2007 certification. It has new chapters included in it and focuses mainly on the benefit-risk ratio. It also includes information that has to be passed on to the next phases for safer use of the device.

EN ISO 14971:2012- It is intended for manufactures of medical devices in Europe only.

The ISO 14971:2019 has three main objectives

Implementing the safety standards right fro he planning phase of manufacturing

Designing medical devices is a complicated process. This feature as stated within the ISO Document Control Software is to mitigate the hazards in the medical industry by use of safe manufacturing process. It deals with removing those features that could be selected by mistake or by error.

The safety while using the medical devices can also be increased by the use of labels and displays beside each switch, plug, or socket. Also, there should be a process to automate the device functions to avoid the error. It can be used for doing the minute tasks where the chances of error are high.  

Include measures to protect or contain the damage within the device itself

This point explains the need to incorporate safety measures in it and also the mechanisms in the event of wrong input. These may include safety measures such as using safety guards, shields, or manual override to contain the activity. It includes providing warning displays to warn the user while using the device such as low battery warnings on devices. This would prevent stalling a device operation midway while conducting surgery or anything similar. 

Safety information

This includes users to hand a device manual which gives a thorough guide on how to use the device. It also includes providing training to the users of the device.

What are the benefits of ISO 14971:2019?

• It can avoid the wrong happenings such as injury or accident
• Optimum use of the device for improving medical infrastructure
• Develop better surgical procedures that focus on the safety of the user and the patient
• Streamlining manufacturing processes and issuing standard guidelines

Orcanos is a risk management tool designed to help medical device manufacturers. It is considered to be the best for providing an integrated solution, providing traceability, and is fully online. Visit the Orcanos website for more details: https://www.orcanos.com/compliance/

Integrated Design Control and QMS

To introduce, ISO 9001 QMS (Quality Management Standard) was designed and introduced by the ISO to help organizations ensure a better quality of products and services to be able to grab a larger market share and ensure greater customer satisfaction. A strong QMS is a necessary part of achieving prime quality to please customers. The QMS aids in making and maintaining the simplest set up of action for doing business. The QMS systems provide a way to deal with problems requiring corrective action and for determinant causes of insubordination. The QMS and audit system also produce a mechanism for implementing preventive actions to eliminate the foundation reason for quality problems. As a result, if the very best quality isn't achieved, the system itself is the instrument for correcting that.

A QMS Quality Management System is required for any organization which desires to demonstrate its ability to consistently provide products that meet both customers' needs and the applicable regulatory requirements. When a Quality Management System; is implemented, it paves the way for an integrated enterprise with interacting processes. This helps in the smooth functioning of the operations resulting in profitability. QMS helps to efficiently control business processes and their interlink ages. Furthermore, it can help you in overcoming market barriers paving the way to fiercely compete in global markets.

Perhaps one of the more important aspects of a QMS is that you'll be able to make continual improvements in how you run your company. From managing your risks better to driving down operating costs, from improving your market share to increase your customer satisfaction, your QMS will provide you with an edge over all your competitors. Also, once you get outside certification for your QMS, particularly for international standards such as the widely used ISO 9001, your business attracts new clients.

In the year 2005, the company named Orcanos comes into existence by Zohar Peretz and Rami Azulay. The only company that provides Integrated Design Control and QMS or Quality Management Software, and ALM (Design Control).Our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers make us unique from others. At any point, Orcanos enables you to get data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records

Integrated Design Control and QMS enable all stakeholders, whether its R&D, QA, RA, or management, working with a single repository system that combines it all together document Control, CAPA, Change Control, Risk Management, Requirements Management System, and more. We are also flexible enough to serve SMBs and powerful for enterprises. ORCANOS CAPA (Corrective Action and Preventive Action) ensure regulations compliance while automating the CAPA process completely, from initiation to investigation and closure. To know more about Orcanos or more please, call us at 3-5372561 or visit our website HERE; https://www.orcanos.com/compliance/

How To Ensure Integrating Design Control, Quality And Regulation Compliance?

If you own an organization in highly regulated industries such as life sciences, it is important to make sure that everything is dotted and crossed. Today, the US FDA and other regulatory agencies have strict regulations and requirements for document control, integrating design control, CAPA, training and other aspects of the operations. As an organization owner, you have to make sure that your each and every process must support continuous compliance and your organization needs to be ready to respond to any kind of requests for regulatory changes or documentation. If you are someone who is just getting started then ensuring your procedures and processes are complaint can feel like a daunting and overwhelming task. Your organization need to create and implement a well-designed quality management system which can scale.

In this article, we will tell you how to ensure that your organization maintains Integrating Design Control, Quality And Regulation Compliance and the best company that provides all these software tools and services. As an organization owner, you need to know that your organization will be responsible for creating a good quality management system (QMS) which will greatly help you bring products to market that meets the requirements of regulatory agencies and also your customer needs. A quality management system (QMS) is defined as a set of comprehensive business procedures and processes that are designed to meet customer requirements and also create quality products. So, it is very important to ensure that the quality management system should be aligned with regulatory requirements.

Orcanos is the one such leading company that serve high-tech industry-leading companies and specializes in medical device manufacturers. Orcanos provides a continuous real-time audit for medical device and compliance medical device lifecycle management. Our holistic approach supports senior management, R&, and QA/RA. Orcanos Integrating design control software enables medical device manufacturers to provide documented evidence that a well defined and controlled product development and design process is in the right place and has been properly executed and manufactured. This collaborative design control software improves regulatory compliance and design quality through best tools that enable you to record and review design evidence and stay on top of the design history and key activities.

Orcanos Application Lifecycle Management (ALM) provides FMEA  risk management, document management, requirements management, test management and quality management processes and procedures everything on a single respiratory. Orcanos requirements management tool is the one-stop affordable cloud solution for managing and tracking testing and requirements as part of Orcanos integrated ALM and QMS platform. One of the biggest advantages and the great power of Orcanos is in the integration between design control, quality, R&D and regulation. To know more details and information about Orcanos please visit our website here: https://www.orcanos.com/compliance/

Benefits of implementing the QMS

Companies that are involved in designing and manufacturing of any types of devices need to adopt the quality management system into their organization. As the name suggests, the quality management system is a set of policies and procedures aimed to make sure the right product quality.

Adopting the set of rules stated in the quality management system abbreviated as QMS helps to manufacture goods that are of the optimum quality and homogeneous.

Is there any standard available for QMS?

The basic standard has been set by ISO (International Organization for Standardization) in the ISO 9001:2015. It specifies in detail what the scope of the QMS Quality Management System is. All the companies, industries, and factories must adopt to these sets of rules for meeting the standards set by the ISO.

QMS is a very broad concept and so there are other series of ISO standards that focus on certain aspects of QMS. The ISO 14000 series is improving environmental management systems, ISO 13485 for maintaining QMS for medical devices, ISO 19011 audit management systems, etc.

There are many benefits of implementing the ISO.

• It helps to meet the requirement of your customers and clients. This gives confidence to the customer that your product is safe to use and thus they eventually become hooked to your set of products.
• It ensures making the best quality products at the optimum cost. Thus adopting the ISO is beneficial for cost-cutting and improving profit and revenues.
• It helps to identify, define and improve the process involved in manufacturing and designing
• It makes sure that there are no mistakes during the product manufacturing process and all the products are alike.
• Adopting the QMS also helps in reducing wastes as you have to deal with wastes properly.
• Lowering the cost associated with manufacturing goods.
• Providing proper training to the staff so that they become efficient workers.
• Being consistent in delivering the results.

What are the different elements or levels in a QMS?

Manufacturing of goods is a big process that can be subdivided based on the category of work they do. QMS tries to implement the rules for each of these processes. These elements are-

• The policy of an organization and its quality meeting objectives
• Quality manual
• Procedures and instructions
• Managing data
• Internal process
• Quality analysis of the products

Introducing and implementing the QMS in your manufacturing process

The steps to implement QMS can be divided into 7 steps as follows-

• Designing the product according to standards
• Manufacturing the product
• Testing the product before release so that it meets quality standards
• Correcting the flaws of the product
• Improving the entire process for better efficiency

If you want to implement QMS for medical devices and need help then you can visit the Orcanos website. It will provide you with integrated solutions for implementing QMS easily. For more information about please, visit https://www.orcanos.com/compliance/

Requirements management tool for medical devices

A company involved in the manufacturing and design of medical devices has to spend a lot of time on research in design and development. Companies spend millions of dollars and manpower just to design the framework of the manufacturing process and making guidelines for the safety of the device.

What is the need for a requirement management tool?

If the fault or an error is found in the device it can lead to a recall of the device. This will hamper the reputation of the company manufacturing the device. The sale of its medical equipment may fall and clients may retract their orders.

If the lives of the patient are at stake due to any technical glitch then the situation is even worse. This could also lead to fines by regulating bodies and your company may even lose license for manufacturing medical devices.

How can a requirement management tool help the manufacturing industries?

The use of a requirement management tool is to help the device manufacturing and designing team in three parameters.

Finding our the requirement of a medical device

This is important to start the design process. A medical device should be manufactured to help surgical and operating procedures and save lives. This is done to ease the workload of the medical personnel as well.

Mitigate risk

It is done to mitigate risk especially the mishaps and unfortunate events. If the lives of patients are compromised due to faulty equipment then you have to face lawsuits in the court rater than designing medical devices.

Do case-wise testing

The testing phase will enable the experts to find out all the cases and possibilities while doing the testing. Emphasis is given to all the operating procedures of the equipment based on certain conditions.   

What are the things that you have to consider choosing a best requirement management tools?

Finding out traceability

Traceability is a term that increases the efficiency, and risk in designing and manufacturing procedures. It is an important parameter that helps you to focus on the functionalities of your medical device.

Will the tool help you to identify the risks

Risk management is very important both in the design process and when it is being used in medical institutions such as hospitals and pathology centers. It helps you to find out the design flaws or loopholes in the device that may cause an accident.

Ease of use

It is very important to look at how easy it is to use your requirements management tools. As it will be used by the design and development tool you have to ensure that all your staff knows how to use the tool to adopt safer practices.

Are you searching for the right tool? Then visit Orcanos website because they have the right tool for all types of medical devices manufacturing industries. For more information about please, visit https://www.orcanos.com/compliance/  

Complete Automation of CAPA Process in Orcanos QMS

The Corrective and Preventive Action also referred to as CAPA is a very important integral part of any quality management system for pharmaceutical industries. Having an effective CAPA ensures that your company or organization is constantly working towards reducing the failures in the production, weakness, or testing of drugs and digging deeper for investigating the root causes and problems and then learning and improving them from these causes. The corrective and preventive actions empower the organization to correct the existing nonconformity of product and quality issues and then preventing the occurrence of the problem. If the FDA auditor is not satisfied with your quality management system (QMS) to manage CAPA then as an organization owner, it may cost you with a penalty and you may receive a warning letter.

The perception about CAPA differs from company to company; some think CAPA as some kind of task given to them to complete in order to stay compliant, while others look at CAPA as a number based metric that needs to be reduced immediately. But you need to know that CAPA is actually used to effectively manage the complete lifecycle and in simple words, it is also defined as a system which provides the tools for the complete evaluation, identification and investigation of a deviation. CAPA empowers quality management system (QMS) to be self-correcting and the tools are used to determine, implement and check the effectiveness of a resolution.

Today, most of the companies using a manual paper-based system for managing CAPA and this are the reason; all those companies are facing complexities such as:

• Poor communication
• Poor CAPA reporting
• Unsecure system and error-prone
• Lack of CAPA oversight
• Consume cost, efforts and time

Orcanos is the only reputable company that provides CAPA automation software which is specially designed after experiencing the industry-wide requirements to effectively manage the process. And this software is also used to integrate it with another quality process for attaining compliance. Orcanos CAPA automation software solution helps an organization to get complete automation of CAPA process in Orcanos QMS System and also make sure that all measures are identified to solve the issues and also ensures that the complaint related to quality is taken care of. It also provides a single unified platform for electronically evaluate, identify, analyze and investigate the incidents and also helps to make sure that similar types of errors are not repeated.

Orcanos CAPA management system as part of Orcanos Quality Management System (QMS) ensure all the regulation compliance, while completely automating CAPA process from the beginning stage to investigation and closure. Our Orcanos CAPA system is fully integrated with Orcanos electronic quality management system (e-QMS) to support medical device compliance. To know more details about Orcanos please visit our website here: https://www.orcanos.com/compliance/

ISO Standards 101 - Understanding the basics of ISO Quality Management Systems

There are more than enough ISO standards to confuse any organization that's looking forward to getting certified. Today, there is more than 16,000 point of compliance being used by certifying bodies to assess, monitor and audit any organization seeking to improve its quality management system. Here is a brief explanation of what these standards are and their specific usages:

ISO Standards

ISO9000 compliance contains the metrics or specifications required in order to attain the guidelines or criteria specified under that series. These standards referred to as the in order to group the compliance guidelines used for quality management and assurance. An International Standards Organization is identified as the series and its version. For example - the ISO9000:  family of quality management.

ISO 9000: This is a very popular standard, starting from ISO9001 to ISO9999. The ISO 9000 family of standards deals mainly with the use of quality management systems to make sure that the customers and clients of an organization have their needs met. Over one million organizations are ISO 9000 certified worldwide, making it one among the foremost used standards created by the international organization of Standardization. When organizations are ISO 9000 certified, they're telling their customers that they want to deliver quality products and services to them, also as communicating that they have plans in place to ensure that quality is always managed and is one of the organization's biggest concerns.

The International Organization for Standardization (ISO) was established with the purpose to ensure and supervise the quality of products and services, which created the Quality Management System (QMS) standards in 1987.  According to these standards, there are certain basic principles for quality management, which are-Customer Focus, the involvement of individuals, evidence-based decision making, and relationship management.

In the year 2005, the company named Orcanos Software comes into existence by Zohar Peretz and Rami Azulay. The only company that has integrated software for ALM (Design Control) and quality management (QMS). ORCANOS CAPA (Corrective Action and Preventive Action), as part of Orcanos QMS, ensure regulations compliance, while automating the CAPA process completely, from initiation to investigation to its closure. The thing which makes us unique from others is our years of proven experience in a regulated hi-tech industry, operating with medical device manufacturers and other advanced corporations and assisting them in building their operational excellence.

Which ISO standard is right for your company?

The choice of ISO standard your organization will apply for will depend on the kind of company you have, the nature of its business, its production or manufacturing processes, the type of products and/or services involved and the quality management system you want to achieve.

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