Cost savings and improved efficiency with Compliance Navigator
Micron Corporation specialises in the development and manufacture of dental equipment. We spoke to Mr. Yutaka Kadota, the manager of the Quality Management Department, about how the company is using Compliance Navigator and about many of the features his team finds helpful.
“We are completely free from restrictions. All team members are able to view documents, which is a great help.”
Background
Micron Corporation is a medical device manufacturer engaged mainly in the development, manufacture, sales, and export of dental equipment. Its major products include dental air scalers, tooth surface cleaners, dental root canal enlargers, and dental root canal cleaning, suction and drying devices.
It also manufactures and sells dental examination equipment called hand pieces, performance measurement devices, and other products. The Quality Management Department handles tasks for regulatory affairs in addition to controlling the quality of products.
Customer need
The department has to spend a large amount of time researching standards. “There are many websites that we must visit, to collect all the information about publication and the revision of standards and regulatory documents,” says Mr Kadota. “But our resources are limited. Including myself, there are only two people in the Quality Management Department in charge of research and pharmaceutical affairs. We spend a great amount of time on those tasks.” Many of the standards face revision, and there are not many that allow for a transition period afterwards. For example, if a standard is revised just before a product is examined by a certification body, manufacturers must respond promptly to the revision. So Micron needs to find out about revisions beforehand. The team regularly visited the websites related to committees of the ISO and European standards to check for revision schedules.
In addition, the changes in the revised standards are not clearly indicated. This makes gap analyses between the old and new standards time-consuming and troublesome. Micron tried to compare contents of old and new standards automatically by using commercially available software, but this did not work effectively because standards purchased as PDF files are usually protected. All Micron could do was to check for differences manually and visually, and sort the content by requirement on Excel to compare them. “We also attended seminars about the more challenging regulations and standards. However, in many cases seminars were not provided in the period we desired, and MDR seminars are not provided on a timely basis either,” says Mr Kadota. “In these cases, we were left wondering how to interpret regulations and standards.”
“Once you have used it, you will find it difficult to go back.”
The solution
Micron Corporation adopted Compliance Navigator to address the biggest challenge facing the Quality Management Department: trying to anticipate changing standards in the face of limited resources, language barriers, time-consuming processes, and inconsistent information from widespread sources.
“The greatest benefit of Compliance Navigator is that we are able to view standards online, wherever we are” says Mr Kadota. “Previously, we purchased BS, EN, and ISO standards from the Japanese Standards Association. This involved restrictions, including a copyright restriction that permitted the printing of only a part of the documents and prohibited the distribution of photocopies. With Compliance Navigator, we are completely free from these restrictions. All team members are able to view documents, and printing and downloading is also permitted, which is a great help.”
“We are able to view standards online, wherever we are... [and] we no longer miss new information, which is a great help"
Customer benefits
Because there are links to other clauses in the text of the standards, users can immediately go to the other sections or pages to see the information they need. Links to normative or informative standards are also provided, which they find very useful. Mr Kadota explains: “for example, if one standard requires the use of a test method that is defined in another standard, we normally have to purchase that standard just to fulfil that single item. Compliance Navigator allows us to refer to other standards as necessary, which is a great help in terms of cost as well.” Compliance Navigator shows the status of revisions on pages of the standards that are scheduled to be revised, and also sends email notifications. Mr Kadota cites an example: “Only a few days ago, we received a list of added content. We checked it immediately because the Track of Changes to ISO 14971:2019 is relevant to us. Thanks to email notifications like this, we no longer miss new information, which is a great help.”
What’s more, when Compliance Navigator notified Micron that a standard regarding the information provided by medical devices manufacturers would be revised (one of those listed in the MDD harmonised standards), the team was able to see the draft of the standard from the link immediately. Compliance Navigator also informed them that the standard would be replaced from the EN to ISO. Previously, they could not have obtained information like this in advance. As Mr Kadota says, “If we are able to read the draft at that phase, we are able to identify matters that require us to prepare and take other actions. We can also share information about the most recent developments with people in R&D department. In this case, there were many explanations about the labelling of medical devices, and the change to ISO resulted in the expansion of the scope of application, which had the potential to greatly impact our company. So the availability of the draft helped us a lot.”
One major concern for Mr Kadota was that old versions of standards would not be replaced so that the volume of data on individual computers would continue to increase. But now that they are consolidated online with Compliance Navigator, his team is always able to access the latest version without concern. Mr Kadota praises the Document Records feature. “In the profiles of products we sell in Japan, we create links to documents that are required for the medical devices certification. For example, we create links to ministerial ordinances, notifications, and JIS standards, which can be immediately referred to from the Compliance Navigator. It is difficult to bookmark and manage a large number of reference websites, such as the notifications from the Ministry of Health, Labour and Welfare and the Pharmaceuticals and the Medical Devices Agency (PMDA), and the JIS standards disclosed on the JISC website. Compliance Navigator allows us to manage the necessary documents in one location.” In Compliance Navigator, the text of the standards can be viewed in a browser, enabling the use of Google Chrome’s translation feature. Mr Kadota points out that browsers have other benefits too. In browsers, you can copy and paste text without unwanted line breaks, which enables the smooth creation of checklists. A table of contents is also displayed in the navigation pane on the side. The Smart Support documentation on MDR gap analysis was also a great help. “Other resources on MDD and MDR gap analysis are extremely limited,” explains Mr Kadota. “And in many cases, seminars provided by certification bodies or similar organizations do not cover gap analysis, clearly indicating that it is not included. They probably want to avoid definite judgments and interpretations. However, referring to Smart Support on Compliance Navigator enabled us to do MDD/MDR gap analyses. It was a very helpful document.” The Quality Management department also refers to Compliance Navigator’s expert commentary and would like to take full advantage of other features more. Recently, Micron’s R&D department has also begun to use it. The greatest advantage of Compliance Navigator is the increase in efficiency, Mr Kadota concludes.
