Quality Management


At LFH Regulatory, we understand that a robust Quality Management System (QMS) is the cornerstone of ensuring the quality, safety, and effectiveness of medical products. Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.  

Why Choose LFH Regulatory for Your Medical Device QMS?

Ensuring quality is essential in the medical device industry. Patient safety, regulatory compliance, and market success all hinge on the quality and consistency of your medical products. Our QMS solutions provide the structure, control, and effectiveness you need to achieve and maintain excellence. We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.

Comprehensive Quality Management Systems

We assist with a variety of quality management systems tailored to the markets you wish to enter:    

ISO 13485:2016 - The International Benchmark

ISO 13485:2016 is an internationally recognised standard that offers a robust framework for establishing and maintaining your quality management system for the UK and European markets. This standard is also recognised in other global markets, providing a strong foundation for achieving compliance and excellence.

Medical Device Single Audit Program (MDSAP) - Simplifying Multinational Compliance

The Medical Device Single Audit Program (MDSAP) streamlines your QMS through a single audit process that satisfies the requirements of multiple regulatory jurisdictions. This program encompasses countries like the United States, Canada, Brazil, Australia, and Japan. MDSAP uses ISO 13485 as its framework but incorporates country-specific regulatory requirements, including market authorisation, registration, and adverse event reporting. It simplifies the complex landscape of global compliance without diminishing product-specific approval or registration requirements in individual countries.  

21 CFR Part 820, Quality System Regulation (QSR) - Meeting US Requirements

For those targeting the US market, compliance with 21 CFR Part 820, known as the Quality System Regulation (QSR), is imperative. It involves establishing and maintaining a quality system to ensure your medical device meets the applicable requirements and specifications. Our expertise in this area assists you in navigating the specific requirements of the FDA, ensuring your products can access the vast US market.  

Quality Management Review Pathway: Maximising Efficiency

If you already have an established QMS, our Quality Management Review Pathway offers an effective means of enhancing its efficiency and compliance. This pathway includes:  


  1. Review of Your Current QMS Status  : An in-depth analysis of your existing QMS. 


  1. Gap Analysis and Potential Solutions  : Identifying non-conformances and proposing solutions. 


  1. Creating a Plan to Bridge Gaps  : A strategic plan for addressing gaps. 


  1. Implementing and Remediating Gaps  : Executing the plan to ensure QMS compliance. 

How We Help: Tailoring Your QMS for Success   

Understanding your organisation’s unique infrastructure is pivotal to developing and implementing an effective QMS. Our QMS development process involves a thorough review of your operations, ensuring that your QMS seamlessly integrates with your day-to-day activities. Tailoring your QMS to your specific needs promotes efficiency, quality, safety, and reliability in your devices.  


Maintaining Your QMS: Ongoing Support for Success   


Once your QMS is implemented, ongoing support is essential to keep it current and compliant with applicable standards. Our support services include reviewing and updating procedures, conducting internal and supplier audits, managing non-conformances, implementing corrective and preventive actions, and handling complaints. We ensure that your QMS remains robust and adaptable.  


 Next Steps: Empowering Your Quality Management   


At LFH Regulatory, we provide next-level support to facilitate systemic changes within your business from the ground up. Contact us today to discuss your requirements and learn more about how our QMS expertise can elevate the quality, safety, and compliance of your medical devices. 

Medical Device Software
We specialise in navigating the unique challenges of medical device software, ensuring compliance and safety in this increasingly vital field. From data security to user interface design, we are your partners in ensuring that software-driven devices meet regulatory standards.
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UK Responsible Person
For manufacturers located outside the UK, we serve as your trusted UK Responsible Person, facilitating compliance with UK regulations. Our expertise in UK MDR 2002 ensures that your devices can access the UK market efficiently and effectively.
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Global Registrations
We streamline the complex process of global registrations, ensuring your products can reach international markets. From the EU to the USA and beyond, we manage the intricacies of diverse regulatory requirements.
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Empower your team with regulatory expertise through our comprehensive training programs. Our training covers all aspects of medical device regulations, ensuring your team is well-equipped to navigate the ever-changing regulatory landscape.
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