Medical Device Compliance: Why was QMSRegs Created?

Our mission is to ensure your business achieves Medical Device Compliance in the UK and EU through easy to edit templates.

QMSRegs was founded in 2020 by the Patient Guard group to help start-ups, SMEs and spin out companies get their medical devices to market and achieve Medical Device compliance. As medical devices become more complex with technology and regulation becomes tighter, it can be a confusing arena to navigate through, especially for start ups, SMEs and spin out companies, they have great innovative ideas, but struggle to get them off the ground due to budgeting constraints or pressure from investors.  

Our Templates

Our easy to use templates can be downloaded on an individual basis for those looking to fulfil a particular part of a requirement, or can be purchased in bundles as a whole package. By buying templates in bundles customers will save money and time which, can be put towards other vital objectives to achieve Medical Device compliance. We provide folder structuring templates for purchase, mapping out an easy formatting structure for your Quality Management System and technical files. The editable template versions are purchasable from the QMS & Regulatory Templates sections below. We have given all our templates the document number relevant to the associated clause in the applicable standard for ease of identification. QP stands for Quality Procedure, QR stands for Quality Record in the title of the template. 

How do our templates help?

Our templates provide an excellent, detailed framework which can be customised in order to create a finished record or procedure for your QMS. Not only will these procedures help your organisation demonstrate compliance with the associated standard, and bring you closer to certification, but we're sure you will find they benefit your organisation in other ways too. Many customers find that by using the templates, they begin to consider aspects of business planning and continuity that they hadn't previously, leading to improved processes, reduced expenses, better practice and more!

To get a better idea of what templates may benefit you most, the Quality Manual PDF linked above will help you assess which procedures might apply to your medical device(s). Depending on your product, you may find that some ISO 13485 clauses do not apply, such as certain aspects of clause 7 will only apply to sterile devices. Therefore, you may find certain templates are not necessary to build your QMS. We always recommend that your review the Quality Manual and the standard carefully before deciding what templates are right for you. If you need any assistance, our friendly team are always available to help. Drop us an email or book a free consultation with our consultants at Patient Guard.