Medical Device Case Studies

We introduce cases that MK Consulting has handled, from preparing required documents and product prototypes to coordinating with stakeholders in Japan and overseas. See the work we performed and the outcomes of our support in regulatory submissions, clinical evaluation, quality management and product development.

Company and product names are withheld to protect confidential information.

Completed Cases

End-to-end support for ISO 13485 certification, starting with documentationISO 13485 certification obtainedFor a Japanese medical device manufacturer seeking initial certification, we handled the work from preparing required documents through the audit. Our scope also included responding to requests for additional materials during the audit.Support for approval of a pancreatic duct stentMarketing approval obtainedWe organized an evaluation approach using existing materials and identified additional testing, then prepared the submission in coordination with the manufacturer and its Japanese distributor. The pancreatic duct stent concerned obtained marketing approval.Support for QMS document revision and audit preparationAudit response completedWe created and revised quality procedures in response to amendments to the QMS Ordinance and supported preparations for the audit. We also clarified the document issuance and record creation to be performed by the client, and completed our support through the third-party audit.Support for revising a clinical evaluation report and drafting PMDA inquiry responsesReport and draft responses deliveredBased on the PMDA inquiries, we identified what needed to be added to the existing clinical evaluation report, prepared and delivered a revised report and draft responses, and handled further inquiries received after delivery.Support for medical device prototyping from process planningPrototype production completedThis development support progressed from organizing the process and selecting partner suppliers to producing a prototype. The client confirmed completion of the commissioned work.

Ongoing Support Cases

Other cases, including preparation of clinical evaluation reports and certification work, remain ongoing. Here we describe our current work separately from cases completed through approval, certification or market introduction.

Clinical evaluation and Japan entry preparation for an overseas manufacturer

For an overseas medical device manufacturer's preparations to enter Japan, we are preparing a clinical evaluation report and reviewing regulatory documentation. Key tasks include compiling clinical data, drafting the discussion and conclusions, and checking for missing information.

In parallel with document preparation, we are coordinating the division of responsibilities and the approach between the overseas manufacturer and a Japanese distribution partner, working on both regulatory documentation and business-side coordination.

Certification preparation and stakeholder coordination for an overseas medical device

For certification preparation of an overseas medical device, we are reviewing the manufacturer's technical documentation and manufacturing-site information, and identifying additional information needed. Liaison and confirmation with a Japanese marketing authorization holder and the certification body are also within our scope.

Taking account of the state of the documents and the review schedule, we are coordinating responses with stakeholders and continuing practical work toward the application.

Other Support

Documentation for product improvements and design changes

Focusing on plastic stents, we are considering improvements based on physicians' feedback and prototype usability. Drafting documents for changes to materials and manufacturing methods and identifying evaluation items to check after changes are also part of our work.

Procurement of processing equipment and molds

For processing equipment and molds used to manufacture medical devices, we handle specification checks, obtaining quotations, preparing purchase orders, and coordinating order details and delivery destinations. Alongside product development, we also support preparations to introduce the equipment needed for manufacturing.

Coordination for joint development and patent applications

In projects involving physicians, universities and manufacturers, we have participated in confirming intentions regarding joint applications, communications and coordination on confidentiality agreements, and reviewing draft documents prepared by patent attorneys. MK Consulting's role is to organize development-related information and confirm details among the parties; we do not act as a patent filing representative.

Related Services

・Approval, certification and notification support

・Clinical evaluation report preparation

・QMS and business licensing support

・Development and regulatory support for GI endoscopy and biliopancreatic devices

About Fees

Fees depend on the product, the state of the documentation, the requested scope and the preferred schedule. After reviewing your inquiry, we will explain the work required and an approximate cost.

Our quotation distinguishes the work we perform from external expenses, such as testing costs and review fees.

Tell Us About Your Current Challenges

You can contact us even if your product area or development stage differs from these cases. Tell us about the product, your current challenges and the support you need. We will discuss the scope of support and how to proceed after hearing the details.