Background

Medical devices entering the European market must comply with MDR 2017/745. This regulation requires all devices to undergo rigorous audits to achieve CE marking. RISE MNB plays a crucial role in this process by providing certification services that ensure compliance with MDR standards. Additionally, RISE MNB is accredited to issue ISO 13485 and ISO/IEC 17021-1 certifications, with a primary focus on conducting conformity assessments for various device classes.

Goals and Challenges

RISE MNB faced the challenge of digitizing their certification processes to enhance efficiency and transparency. Their goal was to streamline the entire certification workflow, making it easier to manage the multiple review steps involved in medical device approval.

Given the highly regulated nature of their work, RISE MNB needed a solution that could handle complex audit procedures, track detailed documentation, and manage the unique product codes required for each client. Their certification process involved multiple layers of review, including quality checks, standard reviews, and final assessments. These processes required a structured, organized, and fully digitized approach.

During the initial certification process, RISE MNB needs to receive and manage numerous documents, such as Test Reports, in a well-structured and organized manner. These documents are reviewed and assessed according to strict regulations and tight timelines. The Intact Platform is crucial in managing this high volume of documents and their associated findings, streamlining the review process, maintaining compliance, and ensuring all tasks are completed within the required timelines. Additionally, the company needed a platform to manage capacity planning for staff with specialized qualifications. This was essential to meet the legal requirements of Swedish law, which mandates that sufficient capacity is available before conducting an audit.

The Intact Platform’s planning tools also provided proactive scheduling capabilities, ensuring that auditors were matched with assignments aligned with their qualifications. This feature was crucial for managing capacity, forecasting needs, and adhering to legal requirements.

Leveraging the Intact Platform’s real-time compliance tracking for MDR 2017/745 and other relevant regulations, RISE MNB ensures that all regulatory requirements are thoroughly met throughout the certificate creation process.

Although RISE MNB is a relatively new player, their partnership with Intact has already led to significant improvements. By digitizing their processes, they’ve enhanced the structure, transparency, and overall user experience of their certification workflows. This digital transformation not only aligns with their complex operational needs but also positions them for continued growth and success in the medical device certification industry.

RISE MNB Voice

“The controlled review parts are crucial for our operations.”