Software as a Medical Device (SaMD) Compliant: 25+ years of experience
As a software as a medical device (SaMD) manufacturer, you face the challenge of navigating a complex regulatory landscape. Certification Experts is your partner to guide you through this dynamic environment with confidence. We offer:
- Established Reputation: More than 2,000 satisfied clients worldwide
- Extensive Expertise: Over 25 years of experience in medical device certification
- Full-Service Offerings: From classification to clinical evaluation, documentation, and market access
Mastering Software as a Medical Device (SaMD) regulation
SaMD is software used as a medical device to support healthcare decision-making. It falls under strict regulations like the EU MDR and MHRA guidelines to ensure safety and performance. As a manufacturer, you must:
- Determine the right SaMD classification
- Comply with specific quality and safety requirements
- Develop comprehensive technical documentation
- Issue a Declaration of Conformity
Certification Experts guides you through this complex landscape with specialized expertise and a personalized approach.
Classifying and Qualifying Software as a Medical Device
The first step is determining the appropriate SaMD classification, which defines the requirements you must meet. Certification Experts analyzes your software and helps you categorize it into the right risk class:
- Class I: Low risk, such as general health apps
- Class IIa/IIb: Medium risk, like diagnostic software
- Class III: High risk, e.g., active therapy software
We then qualify your SaMD as a medical device and support you in adhering to the relevant regulations and standards.
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Compliance challenges in Medical Devices
Organizations involved in the production or distribution of medical devices face different of legal obligations, particularly under the Medical Device Regulation (MDR), the successor to the Medical Device Directive (MDD).
What are some key points to keep in mind?
- Risk classification under the MDR: With the introduction of the MDR, software is often subject to a higher risk class.
- Quality system according to ISO 13485:2016: To ensure that product(s) and the quality system comply with the requirements of the MDR, organizations implement a quality system that need to be certified.
- Organizations must have a complete technical file, and in most cases, they must submit it to a Notified Body for thorough evaluation by an expert. After a positive assessment, they issue an EC certificate (for product compliance) and an ISO 13485 compliance certificate.
- Registration obligations: Organizations must fulfil various registration obligations, such as registration in EUDAMED
- If your organization is located outside the EU, it must appoint an authorized representative(EC REP) and an importer (IM). Both need to be registered in EUDAMED in these roles.
The importance of a Quality Management System (QMS)
In addition to the aforementioned obligations, the implementation of a Quality Management System (QMS) is essential for manufacturers, distributors, and importers of medical devices. Even if not legally mandated, a QMS can be valuable, for example, as a requirement from suppliers or customers. A QMS provides a structured approach to meeting and maintaining compliance with laws and regulations, ensuring compliance even as laws change.
In collaboration with BMGRIP, Certification Experts can not only guide you with the (e)QMS but also provide you with a digital platform, SmartManSys. SmartManSys is a digital platform that documents processes and product requirements, focusing on process execution and continuous improvement within your organization. It is a platform that simplifies the addition of new standards and the combining of documents, eliminating the need for duplicate work. With SmartManSys’ smart tools, you can easily integrate multiple standards and documents into one comprehensive management system.
Expertise for Software as a Medical Device Compliance
Our experts stay up-to-date on the latest SaMD regulatory developments. We assist you with:
- Technical Documentation: Compiling the required dossiers
- Clinical Evaluation: Assessing clinical performance and safety
- Conformity: Obtaining the CE mark or UKCA mark
- Market Access: Guidance for entering the right target markets
With Certification Experts as your compliance partner and part of the Kader Group, you can confidently bring your software as a medical device to market. We are ready to support you in ensuring compliance with European requirements for your software as a Medical Device. We can assist you with setting up a QMS, obtaining CE marking for your software under the MDR, and even take on the role of Authorised Representative and/or PRRC. Work with Certification Experts to navigate the steps for CE marking of medical devices and ensure that your QMS guarantees and enhances the quality and safety of your software as a Medical Device.
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All the answers you might need!
Yes, software as a medical device (SaMD) must be CE marked to be placed on the European market. The CE mark indicates that the software complies with the relevant EU regulations and directives, such as the EU Medical Device Regulation (MDR).
Certification Experts provides end-to-end support for software as a medical device (SaMD) compliance. This includes determining the appropriate risk classification, developing the required technical documentation, conducting clinical evaluations, obtaining the necessary CE or UKCA markings, and assisting with market access. Our experts guide you through the complex regulatory landscape.
Yes, software as a medical device (SaMD) is considered an active medical device, as it relies on a source of energy to function (e.g., electricity from a computer or mobile device). Active medical devices are subject to additional regulatory requirements compared to passive medical devices.
Software as a medical device (SaMD) refers to software that is used as a medical device to support healthcare decision-making. This includes software applications, algorithms, and programs intended for medical purposes.
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