How MedQdoc helped MedTech start-up Aidee achieve ISO 13485 certification in 12 months
Executive summary – how Aidee achieved ISO 13485 certification
Aidee Health is a MedTech start-up that needed an eQMS to help navigate the regulatory requirements of the industry and bring its innovative blood pressure monitor to market. With MedQdoc, a specialist eQMS for the medical device industry, Aidee was able to establish a robust quality management system and develop the necessary documentation in a fraction of the time, without starting from scratch. This led to Aidee achieving ISO 13485 certification within 12 months of implementing MedQdoc.
How Aidee benefited from using MedQdoc
Using MedQdoc, Aidee was able to:
- Understand and meet regulatory requirements more quickly and easily by using intuitive, ready-to-use, and customisable templates.
- Ensure nothing slipped through the cracks by relying on robust document control.
- Implement a compliant eQMS in an efficient and structured way.
- Become audit-ready faster, reducing the risk of delays in the certification process.
- Embed a quality-focused culture within the organisation from the outset of the project.
“MedQdoc gave us the perfect head start as a business with relatively little experience in the MedTech industry. The eQMS was easy to use and packed with practical guidance that helped us create the documentation needed to demonstrate compliance. We would not have achieved our goal of ISO 13485 certification so quickly if it had not been for MedQdoc guiding us every step of the way.”
Susanne Ludvigsen, CEO, Aidee Health
Who is Aidee?
Aidee Health AS is a Norway-based start-up developing cutting-edge blood pressure monitoring technology to help combat hypertension more effectively. Its innovative solution moves away from the traditional inflated cuff method for measuring blood pressure, which can cause stress during measurement and lead to inaccurate readings.
Aidee’s innovative monitor is a comfortable chest strap that provides continuous, round-the-clock blood pressure monitoring without the discomfort of a constricting cuff. It combines electrical (ECG) and optical (PPG) measurements from the chest strap with an advanced algorithm that accurately calculates blood pressure, which is displayed alongside other monitored parameters in a mobile app.
Not all eQMS solutions are the same
Aidee needed certification in order to launch its blood pressure monitor. The first step was to demonstrate that it had a quality management system that supported ISO 13485 compliance. As a company developing a digital solution, Aidee knew from the outset that it needed an eQMS rather than a paper-based system.
Aidee initially used a competitor’s eQMS at the start of its product development journey, attracted by the supplier’s large international presence and the system’s design for automated design control and risk management.
Aidee was looking for templates to help kick-start the development of its quality procedures and documentation, but found that these were only available as an add-on module at extra cost. The templates were also heavily based on US regulations, with limited focus on ISO 13485 certification, which was essential for Aidee’s path to CE marking in the EU market.
Aidee therefore needed an eQMS that aligned better with its processes and objectives, and got in touch with the MedQdoc team after learning about the system.
Discovering the value of MedQdoc
As a company in the early stages of development, Aidee did not have existing documentation or processes to use as a reference. With limited prior experience in MedTech and its compliance requirements, Aidee needed a robust eQMS that could provide a clear starting point and practical guidance on what was needed to demonstrate compliance.
Aidee therefore revisited its vendor selection process and reviewed the requirements for its eQMS:
- An all-in-one digital QMS with workflows and features built specifically for medical device manufacturers, helping to integrate regulatory standards into operations from the start.
- Easy to navigate, use, and understand for companies new to the MedTech industry.
- Support for ISO 13485 compliance and CE marking for the Norwegian and EU markets.
- Support for future expansion into additional markets and their local regulatory compliance requirements, such as QSR in the US.
- Easy-to-understand templates that provide a straightforward way to create and maintain records, with practical guidance on how to demonstrate compliance.
- An extensive library of preconfigured templates that makes it quick, easy, and efficient to get up and running, even for start-ups.
- An all-inclusive eQMS with no unexpected add-on modules or hidden costs.
- A proven and established eQMS trusted by other medical device quality professionals and organisations.
Aidee found that MedQdoc could meet all of these needs while also guiding the team in a straightforward, practical, and structured way towards establishing a robust and compliant quality management system.
Fast-tracking ISO 13485 compliance with MedQdoc
After transitioning to MedQdoc, Aidee’s team found that the system was more intuitive and informative than the one they had previously used. Unlike many templates on the market that simply copy and paste text from regulations, MedQdoc’s templates were tailored and written by medical device quality and regulatory compliance experts, and provided practical ways to demonstrate ISO 13485 compliance at no additional cost.
This was a major time-saver for Aidee, as the team was able to understand the requirements more easily without having to interpret complex regulations and work out how to demonstrate compliance on its own. By using the built-in guidance, Aidee was also able to create the required documentation without starting from scratch, giving the team more time to focus on other areas of the business.
In addition to MedQdoc’s extensive library of templates, Aidee also found MedQdoc’s document management system invaluable in improving efficiency and strengthening its quality-focused culture across the organisation. With MedQdoc’s document management system, Aidee was able to edit documents without checking them in and out, and work directly in the software without needing to download files separately to local drives. Aidee was impressed by how easy the audit-ready system was to manage and how much it reduced time spent on administration.
By embedding MedQdoc into its processes from the start of the project, Aidee became confident that its quality processes and documentation would stand up to the scrutiny of rigorous auditors. This reduced the risk of having to retrofit documentation or uncover issues at a later stage. This was soon confirmed during Aidee’s successful BSI audit for ISO 13485 certification.
MedQdoc is now Aidee’s primary software system for storing documentation, procedures, and records. The company has used MedQdoc to carry out supplier audits and has now completed its manufacturer selection process. Going forward, Aidee will continue using MedQdoc to create the technical documentation needed for product development.
“We did not expect the audit process to go so smoothly and quickly, but MedQdoc was so logically structured and easy to navigate that we could easily produce anything the auditor asked for, without any running around. As a company new to the industry, it was a real achievement to come out of the audit with only three minor and easily resolved nonconformities. Using MedQdoc’s framework gives me confidence that we will always be audit-ready.”
Espen Westgaard, CTO, Aidee Health
About MedQdoc
MedQdoc is an electronic quality management system (eQMS) designed specifically for the medical device industry. Created by medical device quality and regulatory compliance experts, MedQdoc helps medical device companies reduce time to market through intuitive, easy-to-use, and streamlined tools, templates, and functionalities. Learn more about the MedQdoc eQMS product, or contact our team for a demonstration and see how MedQdoc can support your quality and compliance journey.
MedQdoc is used across the medical device industry
