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QMS Template Packages

ISO 13485 QMS Packages

For medical device organisations at every stage – from startup to scale-up.

If you design, develop, produce, install or service medical devices, you’ll need a Quality Management System aligned to ISO 13485.

Whether you want to build your QMS yourself with expert guidance or have it delivered fully ready, our flexible packages fit your timeline, budget, and resources.

Not sure where to begin? Book a free call and we’ll help you find the perfect fit.

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QMS Packages LFH Regulatory
QMS Packages LFH Regulatory
QMS Packages LFH Regulatory
QMS Packages LFH Regulatory

"We provide cost-effective QMS template packages to offer our clients affordable, high-quality solutions"

Dr Yupei Xiao

QMS Packages LFH Regulatory

You're Not On Your Own

We don’t just hand over templates and leave you to it. Every QMS package comes with real support from qualified consultants, so you get it right the first time.

Enjoy four hours of dedicated support from an experienced Regulatory and Quality Consultant who will help tailor your QMS to your business, answer your questions, and build your confidence.

Not sure which package fits your needs? Before you buy, we’ll meet online to understand your unique requirements and recommend the best option.

Choose The Right Quality Management System For Your Journey

Our tailored packages are built to match your growth stage and compliance requirements. Click to find the tools and support you need to move forward with confidence.

Foundation Launchpad

Build a solid quality management foundation tailored for early-stage product development and initial compliance.

Explore Foundation Launchpad

£5000

£7000

Operational Excellence Kit

Manage your quality system efficiently, even without a physical manufacturing site. Ideal for virtual manufacturers seeking full compliance and operational control.

Discover Operational Excellence Kit

£8000

Total Quality Framework

Take charge of your design, development, and manufacturing responsibilities with our comprehensive, audit-ready QMS. Perfect for established manufacturers aiming for complete regulatory confidence.

See Total Quality Framework

£4000

Regulatory Navigator Toolkit

Simplify your MDR and IVDR compliance with ready-to-use SOP templates designed to
streamline your documentation and meet regulatory demands.

Access Regulatory Navigator Toolkit
Download Brochure for Full Details
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Frequently Asked Questions

Every QMS package includes four hours of personalised consultancy with a qualified regulatory expert. After you receive your QMS documents, we’ll schedule a virtual meeting to guide you through tailoring the templates specifically to your medical device or IVD business. We’ll answer your questions, help align the QMS with your processes, and ensure you understand how to maintain compliance.

Yes, all templates are provided in fully editable Microsoft Word format so you can modify content, add company details, and adjust procedures to fit your product type and operational setup. This flexibility lets you create a QMS that truly reflects your business
needs.

If you are bringing a medical device or in vitro diagnostic (IVD) device to market that falls into a classification higher than Class I (for medical devices) or Class A (for IVDs), ISO 13485 certification is essential. This certification is expected by Notified Bodies as part of the CE marking and UKCA marking processes, and is a key requirement for compliance with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Even for Class I or A devices, ISO 13485 is often requested by major customers such as the NHS.
We understand implementing a QMS can raise ongoing questions. We provide extendedsupport options so you’re never left without guidance. You can contact our support team anytime at info@lfhregulatory.co.uk or call +44 (0)1484 662575 to discuss additional training or consultancy.
Yes. If you require specific procedures or documents not included in the standard packages, we offer bespoke template creation services. Reach out to discuss your unique needs, and we can develop tailored content to support your regulatory and quality compliance.

Our packages are carefully designed for different stages and operational models in the medical device and IVD lifecycle:

  • Foundation Launchpad: Ideal for startups and early-stage developers needing a core QMS to meet initial regulatory expectations and start compliance quickly.
  • Operational Excellence: Designed for virtual manufacuters operating without physical production facilities but responsible for quality oversight.
  • Total Quality Framework: Comprehensive coverage for companies responsible for design, development, manufacturing, and full product lifecycle management.
  • Regulatory Navigator Toolkit: A focused set of SOPs and templates required for MDR and IVDR compliance, perfect for organisations seeking essential documentation quickly.

For detailed inclusions and comparison, please <<Download our brochure>>

If you are bringing a medical device or IVD to market that is higher than a Class I or A, ISO 13485 is essential. This certification is expected by notified bodies for CE marking, UKCA marking, and meeting MDR and IVDR requirements and is also requested by customers such as the NHS, even for Class I/A devices.
The timeframe for implementing a QMS can vary depending on several factors, including the size of your organisation, the complexity of your products, and your existing documentation and processes. Our team is happy to discuss your specific situation in more detail. Importantly, our ready-to-use, editable templates combined with expert consultancy support, help streamline the implementation process and get you audit-ready more quickly.

Choosing the right QMS depends on your company’s stage, manufacturing model, and regulatory responsibilities. If you’re unsure, book a free consultation call with our experts, we’ll guide you to the best option for your business.

Book a Free Call

For early-stage innovators laying the groundwork.

This package gives you a solid starting point for regulatory alignment during product development. Ideal if you’re not manufacturing yet but need to show progress toward compliance.

Includes:
● Key ISO 13485:2016 procedures for design and development
● Risk management, classification, clinical evaluation & technical file templates
● 4 hours of expert consultant support to tailor everything to your business

Download Brochure for Full Details

For virtual manufacturers managing compliance without a factory.

Designed for companies outsourcing production but retaining legal manufacturer responsibilities. Stay in control of quality, traceability, and compliance without the overhead.

Includes:
● Full ISO 13485:2016 QMS tailored for virtual manufacturing
● 30+ procedures including CAPA, complaint handling, vigilance & UDI
● Templates to meet EU MDR, IVDR and UK requirements
● 4 hours of expert consultant support to guide implementation

Download Brochure for Full Details

For manufacturers managing design, development, and production.

A complete, audit-ready QMS for businesses with full manufacturing responsibilities. Ideal if you’re scaling or preparing for certification, notified body audit, or supplier approval.

Includes:
● Comprehensive ISO 13485:2016 QMS
● All core and operational procedures for end-to-end quality oversight
● MDR/IVDR-aligned SOPs, PMS & vigilance templates
● 4 hours of expert support to configure everything to your operation

Download Brochure for Full Details

For organisations needing MDR or IVDR templates only.

Skip the guesswork and save time with ready-to-use, regulator-aligned SOPs. Perfect for teams who already have a QMS and need additional support for CE/UKCA technical documentation.

Includes:
● Core procedures for MDR/IVDR including classification, clinical, PMS, vigilance &
UDI
● Fully editable and audit-ready
● 4 hours of support to integrate with your existing QMS

Download Brochure for Full Details

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