Continuous improvement of QMS (Quality Management System)
The scale of the global medical device market is estimated to be approx. 30 trillion JPY. Many of medical device manufacturers market their products not only in Japanese market but also in other markets. When it comes to regulatory requirements, there are many regulations around the globe such as the Japanese ministerial ordinance on QMS, ISO 13485, an international standard, QSR (Quality System Regulation) of the FDA, etc. Manufacturers must comply with the regulations in the target countries when they import their products.
As medical devices are tools for treatment and diagnosis, performance, safety, and Quality Management System (QMS) ifself needs to improve continously. In order to assist the process of efforts to achieve the continuous improvement, CM Plus offers the following services:
Optimization of Quality Management System
In many cases, Quality Management System itself bloated too much thus too heavy to operate and piles of papers remain after many revisions following findings provided during regular audits performed according to ISO13485.
Depending on the scale of the client's production facilities and the number of items to be manufactured and marketed CM Plus provide our clients with support for re-establishing PDCA-based Quality Management System which is compact and easy to operate.
Support for establishing systems for management review
The heart of QMS is management review in which the management is directly involved in.
CM Plus can optimize the content of management review and study its format in a concrete way thus can help our clients develop a system with which the management can made decisions easily.
Support for reviewing systems for corrective actions and preventive actions
Companies receive findings about corrective actions and preventive actions the most during QMS audits.
What are the true corrective actions? What are approaches for effective preventive actions? From those perspectives, CM Plus will make proposals for reviewing current systems.
Support for design control
For designing new medical devices, CM Plus will help our clients to:
- Clarify requirements
- Convert them into input
- Decide how to proceed with actual designing and developing works
- Prepare output
- Verify output
- Validate output
- Implement risk management at important points
Also, CM Plus provides support for the whole process from preparation of protocols based on PDCA to preparation of reports.
Support for CSV
Incorporation of software into medical devices themselves, selling software separately, use of special software in QMS. Today, use of Computerized System Validation (CSV) is inevitable in the medical device industry. CM Plus provides support for the CSV-related processes from planning to report preparation.
Support for preparing for QMS compliance review
CM Plus offers services such as support for preparation for QMS compliance review to be performed by certificate authorities or PMDA and mock audits.
Support for validation
For installing manufacturing processes into your production facilities, CM Plus can support for the whole process from planning validation to putting reports together. Specifically, we can provide services for sterile processes including validation of related utilities.
Our eLearning service
"Practically-Oriented Training Course on QMS for Medical Devices ISO 13485: 2016 Ver."
CM Plus also offers web-based education and training on ISO 13485.
Key point of Practically-Oriented Training Course on QMS for Medical Devices
The course was developed after the revision of ISO 13485 in 2016. In the course, we provides trainees with basics commentary from the following two point of view while introducing the basics of ISO 13485 requirements: "regulation changes made in the revision published in 2016" and "practice in a concrete way".
"Commentary on Quality Management System Process Diagram"
(From our eLearning, "Practically-Oriented Training Course on QMS for Medical Devices ISO 13485: 2016 Ver." Course 2 Quality Management System)
Support for entering the medical device industry
The scale of the global medical device market is estimated to be approx. 30 trillion JPY and its scale in Japan alone is said to be approx. 2.8 trillion JPY.
Entering into such a market seems attractive. However, there are strict regulations on medical devices because of the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. In other words, there will be high hurdles you need to clear in order to market your medical devices even if some materials and technologies can be applied to medicine.
We establish Quality Management System based on the ministerial ordinance on QMS (ISO 13485) and develop product design based on the Quality Management System thus support our clients in a way by which any of the works necessary would not need to be done again.
An example of steps in Japan
Step1 Marketing business license and registration as a manufacturer
The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices needs to be complied in order to manufacture and market medical devices in Japan.
In addition, a business license will be required for marketing products and registration as a manufacturer will be required for manufacturing products.
Step2 Establishment of Quality Management System (QMS)
For a series of activities about medical devices from designing and developing to manufacturing, releasing, and marketing products, Quality Management System (QMS) will be necessary. Thus, the first thing to do is to establish QMS.
In Japan, this is specified in the MHLW Ministerial Ordinance No. 169 (MO on QMS), which is almost the same with ISO 13485 (2016).
Step3 Notification, application for certification, and application for authorization of medical devices
You will be ready to manufacture products after product designing and development. Then either of notification, application for certification, or application for authorization will be required. The procedure will differ depending on risks of your medical device.
For instance, notification will be required for syringes without needles while application for certification will be required for syringes with needles.
Also, application for authorization will be required for catheters which will be inserted in blood vessels.
Step4 QMS compliance review
In this step, QMS compliance review to see if manufacturing control, quality control, and other control can be done for sure according to the QMS MO and ISO 13485 (2016) after application for certification or authorization. Certification will be granted by the third party certification body and authorization will be granted by Pharmaceuticals and Medical Devices Agency (PMDA).
Step5 Manufacturing and Marketing
When you make application for certification or authorization, you will be allowed to manufacture and market your products only after application form review and QMS compliance review.
Services of providing support for entering the medical device industry
As written above, various works will need to be performed according to the regulatory requirements during the steps. CM Plus provides support for performing those works in various way according to your need; we can provide support for the whole project while we can provide support for part of the project such as validation. Specifically:
Establishment of QMS
We provide support for establishing QMS which is as compact as possible depending on the scale such as supporting the process of preparation of documents necessary for establishing the system or supporting actual operation.
Support for design control
For designing new medical devices, CM Plus helps our clients to do necessary works such as clarification of requirements, conversion of the requirements into input, decision making how to proceed with actual designing and developing works, preparation of output, verification of output, validation of output, and implementation of risk management at important points.
Support for preparing for QMS compliance review
CM Plus offers services such as support for preparation for audits to be performed by certificate authorities or PMDA and mock audits.
Support for validation
For installing manufacturing processes into your production facilities, CM Plus can support for the whole process from planning validation to putting reports together.
Our eLearning service
"Practically-Oriented Training Course on QMS for Medical Devices ISO 13485: 2016 Ver."
CM Plus also offers web-based education and training on ISO 13485.
Key point of Practically-Oriented Training Course on QMS for Medical Devices
The course was developed after the revision of ISO 13485 in 2016. In the course, we provides trainees with basics commentary from the following two point of view while introducing the basics of ISO 13485 requirements: "regulation changes made in the revision published in 2016" and "practice in a concrete way".
