株式会社Berry (Headquarters: Taito-ku, Tokyo; Representative Director: Yuji Nakano) will host a free online webinar on June 26, 2026, from 14:00 to 15:00, to systematically introduce their self-developed cloud eQMS, 'QMSmart.' The webinar is titled: 'Can't Go Back to Paper! In-depth Explanation of the AI-powered eQMS "QMSmart" Developed by a Medical Device Manufacturer: Insights from Frontline Implementation Support.'

This one-hour webinar covers everything from the limitations of paper and Excel-based operations, common QMS challenges, and the necessity of eQMS, to a feature demo, implementation benefits, competitor comparisons, and pricing models of 'QMSmart.' A representative who has witnessed the implementation frontlines of numerous medical device manufacturers will provide all the information needed to make an implementation decision.

[Do you have these concerns regarding QMS operations for medical device manufacturers?]

- Document version control and approval flows are complicated due to paper and Excel-based operations. - It has become chronic to search for records before audits. - The burden on quality departments is increasing due to compliance with ISO 13485 / QMS ordinances. - Due to a lack of human resources, CAPA, training records, and internal audits are often put on the back burner. - Existing eQMS solutions are foreign-made and do not fit Japanese operations in terms of price, UI, and support. - You want to know the latest trends in QMS operations using AI, but information is scarce. - You are considering implementing eQMS but cannot visualize its features, costs, or effects.

[Background and Purpose of the Webinar]

QMS operations at medical device manufacturers face a triple hardship: increasing operational burdens, a shortage of human resources, and rising regulatory compliance costs. Conventional operations using paper and Excel often lead to siloed daily tasks—document management, CAPA, and training—which incur significant labor costs during audit preparation. We hear this reality from many companies.

'QMSmart' is a cloud-based eQMS developed by 株式会社Berry, a medical device manufacturer that also holds ISO 13485 certification, starting from their own quality management challenges. It integrates document management, CAPA, training, internal audits, and supplier management into a single platform, earnestly pursuing the transformation of QMS operations with AI, such as AI-based document checking and diff viewers.

In this webinar, Masaya Sakamoto, who has supported many medical device manufacturers as a sales and customer support lead for QMSmart, will provide a comprehensive 60-minute explanation. He will cover the background of QMSmart’s birth, demo actual functions, discuss implementation results, compare competitors, and explain pricing. This session directly answers questions for those who are curious about eQMS but hesitant to take the first step, or those wondering what QMSmart can do, how much it costs, and how it differs from other solutions.

[Webinar Overview]

- Date & Time: June 26, 2026 (Fri), 14:00–15:00 - Format: Online (via Zoom) - Target: Those considering building a QMS, aiming for ISO 13485 certification, quality assurance departments, R&D/manufacturing departments, management, and anyone involved in medical device quality control. - Organizer: 株式会社Berry - Cost: Free (Pre-registration required)

[Webinar Content]

Part 1: 'What is happening in the QMS of medical device manufacturers now?' We will organize and explain the reality on the ground regarding the limitations of paper/Excel, common QMS challenges, and the necessity of eQMS.

Part 2: 'In-depth explanation of the AI-powered eQMS "QMSmart"' From the background of QMSmart's development to basic functions like document management, CAPA, and training, actual UI demos, implementation benefits, competitor comparisons, and pricing models will be covered comprehensively.

Part 3: 'Q&A Session' Questions will be taken during the webinar.

FACT BOX

  • Source: PR TIMES
  • Category: Event
  • Products / services: QMSmart