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/