For medical device organisations at every stage – from start-up to scale-up
LFH Regulatory has launched a new service: ISO 13485 QMS Template Packages, created to make Quality Management System (QMS) implementation faster, easier, and more cost-effective for medical device organisations.
For companies that design, develop, produce, install, or service medical devices, a QMS aligned to ISO 13485 is essential. LFH Regulatory’s flexible packages are designed to suit any timeline, budget, and resources – whether organisations choose to build their QMS themselves with expert guidance or have it delivered fully ready to use.
Support Every Step of the Way
LFH Regulatory does not simply provide templates and leave clients to navigate the process alone. Each package includes four hours of dedicated one-to-one support from an experienced Regulatory & Quality Consultant. This ensures:
- A QMS tailored to the organisation’s specific needs
- Expert answers to compliance questions
- Confidence that the system is implemented correctly from the start
Before purchase, LFH Regulatory arranges an online consultation to understand each organisation’s requirements and recommend the most suitable package.
QMS Packages Available
· Foundation Launchpad
Provides a solid QMS foundation for early-stage product development and initial compliance.
· Operational Excellence Kit
Enables efficient management of a quality system without the need for a physical manufacturing site. Ideal for virtual manufacturers seeking full compliance and operational control.
· Total Quality Framework
Offers a comprehensive, audit-ready QMS for organisations managing design, development, and manufacturing responsibilities. Perfect for established manufacturers seeking complete regulatory confidence.
· Regulatory Navigator Toolkit
Delivers ready-to-use SOP templates to streamline MDR and IVDR documentation and meet regulatory requirements with ease.
Not sure where to begin?
LFH Regulatory offers a free consultation to help organisations select the package best suited to their compliance journey.
