Quality Management Systems (ISO 13485) for SaMD
A structured system of procedures and processes that we build into your company to make sure your end product is optimal and serves end users well. Safety and quality are a priority.
A Quality Management System (QMS) is a company-level structured system of procedures and processes covering all aspects of Design, Manufacturing, Supply, Risk Management, Management Responsibility, Customer Related Processes and CAPAs. It is a requirement under most jurisdictions for medical device manufacturers and forms an important part of your regulatory strategy.
At Hardian, we like to say that a QMS should be built, not bought, as off-the-shelf eQMS’s can give false assurance of attaining quality by appearing to check off compliance while not being fully functional or appropriate to an organisation’s bespoke needs.
It is important to note that a QMS applies to the company as a whole and is not specific to the product(s), so it requires the input of all staff and not just the quality and regulatory members of the team.
Best Practices
Align with internationally recognised standards.
A QMS is legally required for all medical device software and IVD manufacturers in the EU (see MDR Article (10)9 and IVDR Article 10(8)) and the US (CFR 820 regulations for medical device manufacturers). The international standard for a QMS is mapped out in ISO 13485:2016 which is now accepted by the US FDA and covers most of the requirements for EU MDR Article (10)9/IVDR Article 10(8). Another option for companies with intentions to market in Australia, Brazil, Canada, Japan and the United States is to consider the Medical Device Single Audit Program (MDSAP), to cover these multiple jurisdictions within a single audit rather than multiple for each jurisdiction.
For AI-based SaMD, Hardian also works with clients to ensure compliance to the international standard ISO/IEC 42001:2023 which covers management systems for AI and machine learning.
Case Study
How Hardian solves the problem.
Hardian has worked with multiple SaMD companies such as Neuronostics to establish an eQMS from scratch, guiding them through all of the relevant procedures and processes to successful certification in addition to maintenance activities (where required). We have also worked with clients who already have established off-the-shelf systems in place to improve processes where required.
Our team of qualified auditors can also provide audit preparation, mock audit, and remedial actions prior to your official audits.
Hardian can work with clients to implement your QMS on any platform, including Jira, Google Drive, Sharepoint, Greenlight Guru, Qualio, Radbee, or even Notion.
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